{"protocolSection":{"identificationModule":{"nctId":"NCT01149421","orgStudyIdInfo":{"id":"13631"},"secondaryIdInfos":[{"id":"H9X-MC-GBDN","type":"OTHER","domain":"Eli Lilly and Company"},{"id":"CTRI/2010/091/001444","type":"REGISTRY","domain":"Clinical Trials Register India"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes","officialTitle":"The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients With Type 2 Diabetes Mellitus"},"statusModule":{"statusVerifiedDate":"2015-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-06"},"primaryCompletionDateStruct":{"date":"2011-09","type":"ACTUAL"},"completionDateStruct":{"date":"2012-01","type":"ACTUAL"},"studyFirstSubmitDate":"2010-06-15","studyFirstSubmitQcDate":"2010-06-22","studyFirstPostDateStruct":{"date":"2010-06-23","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-10-03","resultsFirstSubmitQcDate":"2015-01-29","resultsFirstPostDateStruct":{"date":"2015-02-02","type":"ESTIMATED"},"dispFirstSubmitDate":"2011-11-04","dispFirstSubmitQcDate":"2011-11-04","dispFirstPostDateStruct":{"date":"2011-11-10","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-01-29","lastUpdatePostDateStruct":{"date":"2015-02-02","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs)."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"],"keywords":["Type 2 Diabetes","Diabetes","Ambulatory Blood Pressure Monitoring","ABPM","Blood Pressure","Heart Rate"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":755,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1.5 milligram (mg) LY2189265","type":"EXPERIMENTAL","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)","interventionNames":["Drug: LY2189265"]},{"label":"0.75 milligram (mg) LY2189265","type":"EXPERIMENTAL","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW)","interventionNames":["Drug: LY2189265"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo: subcutaneous (SC), once weekly (QW)","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"LY2189265","description":"Administered as a subcutaneous injection once weekly for 26 weeks","armGroupLabels":["0.75 milligram (mg) LY2189265","1.5 milligram (mg) LY2189265"],"otherNames":["Dulaglutide"]},{"type":"DRUG","name":"Placebo","description":"Administered as a subcutaneous injection once weekly for 26 weeks","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)","description":"Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)","description":"Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)","description":"Mean 24-hour diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)","description":"Mean 24-hour heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure","description":"Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)","description":"Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)","description":"Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)","description":"Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)","description":"Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure","description":"Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)","description":"Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)","description":"Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)","description":"Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%","description":"Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of \\<7% or ≤6.5% were analyzed with Chi-squared test/Fisher's exact test.","timeFrame":"Baseline and 16 and 26 weeks"},{"measure":"Number of Participants With Treatment Emergent Adverse Events at 26 Weeks","description":"A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes","description":"Amylase (total and pancreas-derived) and lipase concentrations were measured.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks on Serum Calcitonin","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)","timeFrame":"Baseline, 16 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval","description":"The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Number of Events of Adjudicated Pancreatitis up to 26 Weeks","description":"The number of adjudicated (by an independent Clinical Endpoint Committee \\[CEC\\]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 26 weeks"},{"measure":"Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks","description":"Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 26 weeks"},{"measure":"Anti-LY2189265 Antibodies","description":"LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 16 and 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (30 weeks). The number of participants with initial postbaseline detection of treatment-emergent (defined as a 4-fold increase in the ADA titer from baseline) anti-drug (LY2189265) ADA at each time point were summarized.","timeFrame":"Baseline, 16, 26, and 30 weeks"},{"measure":"Rate of Hypoglycemic Episodes","description":"Hypoglycemic events (HE) were classified as severe (defined as an HE requiring assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter \\[mmol/L\\]), asymptomatic (defined as an HE without typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), nocturnal (defined as any HE occurring between bedtime and waking with a measured blood glucose of ≤3.9 mmol/L), or non-nocturnal. Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Logit link. Negative binomial mean was adjusted by treatment, visit, and visit by treatment interaction. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Change From Baseline to 16 and 26 Weeks in Body Weight","description":"Least Squares (LS) means was calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","timeFrame":"Baseline, 16 and 26 weeks"},{"measure":"Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)","description":"The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve \\[AUC\\] at steady state from time zero to 168 hours after study drug administration). Evaluable pharmacokinetic concentrations from the 4, 8, 12, 16, and 26 weeks timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.","timeFrame":"4, 8, 12, 16, and 26 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening\n* Glycosylated hemoglobin (HbA1c) value ≥7% and ≤9.5% at screening\n* Mean blood pressure \\>90/60 millimeters of mercury (mmHg) and \\<140/90 mmHg at screening\n* If treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening\n* Stable weight for 3 months prior to screening\n* Body mass index (BMI) greater than or equal to 23 kilogram-meter squared (kg/m\\^2)\n* Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions\n* Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control\n* Male participants must use a reliable method of birth control\n\nExclusion Criteria:\n\n* Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening\n* Ongoing or history of frequent intermittent tachyarrhythmia\n* Resting heart rate \\<60 beats per minute (bpm) or \\>100 bpm at screening\n* Work rotating shifts or work during the hours of 2200 to 0700\n* Chronic insulin therapy\n* Use of a glucagon-like peptide 1 (GLP-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening\n* Nondominant arm circumference \\>42 centimeter (cm)\n* Use of drugs to promote weight loss\n* Chronic use of systemic steroids\n* Gastric emptying abnormality or bariatric surgery\n* Hepatitis, other liver disease, or alanine transaminase (ALT) \\>3 times the upper limit of normal\n* Acute or chronic pancreatitis\n* Severe renal impairment\n* Active autoimmune disease or uncontrolled endocrine abnormality\n* Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia\n* Calcitonin value greater than or equal to 20 picograms per milliliter (pg/ml) at screening\n* Transplanted organ except corneal transplants\n* Active or untreated cancer or in remission \\<5 years, except skin, in situ cervical, or prostate cancer\n* Sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with HbA1c testing","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Phoenix","state":"Arizona","zip":"85013","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Greenbrae","state":"California","zip":"94904","country":"United States","geoPoint":{"lat":37.94854,"lon":-122.5247}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Lancaster","state":"California","zip":"93534","country":"United States","geoPoint":{"lat":34.69804,"lon":-118.13674}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Los Angeles","state":"California","zip":"90057","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Sacramento","state":"California","zip":"95825","country":"United States","geoPoint":{"lat":38.58157,"lon":-121.4944}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Spring Valley","state":"California","zip":"91978","country":"United States","geoPoint":{"lat":32.74477,"lon":-116.99892}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Coral Gables","state":"Florida","zip":"33134","country":"United States","geoPoint":{"lat":25.72149,"lon":-80.26838}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Daytona Beach","state":"Florida","zip":"32114","country":"United States","geoPoint":{"lat":29.21081,"lon":-81.02283}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Orlando","state":"Florida","zip":"32806","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tampa","state":"Florida","zip":"33613","country":"United States","geoPoint":{"lat":27.94752,"lon":-82.45843}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Winter Haven","state":"Florida","zip":"33880","country":"United States","geoPoint":{"lat":28.02224,"lon":-81.73286}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Cartersville","state":"Georgia","zip":"30121","country":"United States","geoPoint":{"lat":34.16533,"lon":-84.80231}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Gainesville","state":"Georgia","zip":"30501","country":"United States","geoPoint":{"lat":34.29788,"lon":-83.82407}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tucker","state":"Georgia","zip":"30084","country":"United States","geoPoint":{"lat":33.85455,"lon":-84.21714}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Honolulu","state":"Hawaii","zip":"96814","country":"United States","geoPoint":{"lat":21.30694,"lon":-157.85833}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Idaho Falls","state":"Idaho","zip":"83404","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bloomington","state":"Indiana","zip":"47403","country":"United States","geoPoint":{"lat":39.16533,"lon":-86.52639}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Indianapolis","state":"Indiana","zip":"46260","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Louisville","state":"Kentucky","zip":"40217","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Paducah","state":"Kentucky","zip":"42001","country":"United States","geoPoint":{"lat":37.08339,"lon":-88.60005}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Metairie","state":"Louisiana","zip":"70006","country":"United States","geoPoint":{"lat":29.98409,"lon":-90.15285}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Auburn","state":"Maine","zip":"04210","country":"United States","geoPoint":{"lat":44.09785,"lon":-70.23117}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Columbia","state":"Maryland","zip":"21045","country":"United States","geoPoint":{"lat":39.24038,"lon":-76.83942}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Haverhill","state":"Massachusetts","zip":"01830","country":"United States","geoPoint":{"lat":42.7762,"lon":-71.07728}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Springfield","state":"Massachusetts","zip":"01199","country":"United States","geoPoint":{"lat":42.10148,"lon":-72.58981}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Detroit","state":"Michigan","zip":"48201","country":"United States","geoPoint":{"lat":42.33143,"lon":-83.04575}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Jackson","state":"Mississippi","zip":"39216","country":"United States","geoPoint":{"lat":32.29876,"lon":-90.18481}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Jefferson City","state":"Missouri","zip":"65109","country":"United States","geoPoint":{"lat":38.5767,"lon":-92.17352}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Omaha","state":"Nebraska","zip":"68124","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Albuquerque","state":"New Mexico","zip":"87106","country":"United States","geoPoint":{"lat":35.08449,"lon":-106.65114}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Garden City","state":"New York","zip":"11530","country":"United States","geoPoint":{"lat":40.72677,"lon":-73.6343}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Dayton","state":"Ohio","zip":"45439","country":"United States","geoPoint":{"lat":39.75895,"lon":-84.19161}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Jefferson Hills","state":"Pennsylvania","zip":"15022","country":"United States","geoPoint":{"lat":40.29118,"lon":-79.93199}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Johnstown","state":"Pennsylvania","zip":"15905","country":"United States","geoPoint":{"lat":40.32674,"lon":-78.92197}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Austin","state":"Texas","zip":"78728","country":"United States","geoPoint":{"lat":30.26715,"lon":-97.74306}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Georgetown","state":"Texas","zip":"78626","country":"United States","geoPoint":{"lat":30.63269,"lon":-97.67723}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Houston","state":"Texas","zip":"77034","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Salt Lake City","state":"Utah","zip":"84124","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Renton","state":"Washington","zip":"98057","country":"United States","geoPoint":{"lat":47.48288,"lon":-122.21707}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Vancouver","state":"Washington","zip":"98664","country":"United States","geoPoint":{"lat":45.63873,"lon":-122.66149}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Buenos Aires","zip":"1657","country":"Argentina","geoPoint":{"lat":-34.61315,"lon":-58.37723}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Caba","zip":"C1050AAK","country":"Argentina"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Mar del Plata","zip":"B7600FZN","country":"Argentina","geoPoint":{"lat":-38.00042,"lon":-57.5562}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Mendoza","zip":"5500","country":"Argentina","geoPoint":{"lat":-32.88946,"lon":-68.84582}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Santa Fe","zip":"3000","country":"Argentina","geoPoint":{"lat":-31.64881,"lon":-60.70868}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Rio de Janeiro","zip":"22271-100","country":"Brazil","geoPoint":{"lat":-22.90642,"lon":-43.18223}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"São Paulo","zip":"04020-041","country":"Brazil","geoPoint":{"lat":-23.5475,"lon":-46.63611}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Calgary","state":"Alberta","zip":"T2H 2G4","country":"Canada","geoPoint":{"lat":51.05011,"lon":-114.08529}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Red Deer","state":"Alberta","zip":"T4N 6V7","country":"Canada","geoPoint":{"lat":52.26682,"lon":-113.802}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Vancouver","state":"British Columbia","zip":"V6H 3X8","country":"Canada","geoPoint":{"lat":49.24966,"lon":-123.11934}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Victoria","state":"British Columbia","zip":"V8V 3N7","country":"Canada","geoPoint":{"lat":48.4359,"lon":-123.35155}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Winnipeg","state":"Manitoba","zip":"R3P 3P4","country":"Canada","geoPoint":{"lat":49.8844,"lon":-97.14704}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"St. John's","state":"Newfoundland and Labrador","zip":"A1B 3V6","country":"Canada","geoPoint":{"lat":47.56494,"lon":-52.70931}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hamilton","state":"Ontario","zip":"L8L 2X2","country":"Canada","geoPoint":{"lat":43.25011,"lon":-79.84963}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Oakville","state":"Ontario","zip":"L6H 3P1","country":"Canada","geoPoint":{"lat":43.45011,"lon":-79.68292}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Toronto","state":"Ontario","zip":"M4G 3E8","country":"Canada","geoPoint":{"lat":43.70643,"lon":-79.39864}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Laval","state":"Quebec","zip":"H7T 2P5","country":"Canada","geoPoint":{"lat":45.56995,"lon":-73.692}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saint-Laurent","state":"Quebec","zip":"H4T 1Z9","country":"Canada","geoPoint":{"lat":45.50008,"lon":-73.66585}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"České Budějovice","zip":"370 01","country":"Czechia","geoPoint":{"lat":48.97447,"lon":14.47434}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Český Krumlov","zip":"381 01","country":"Czechia","geoPoint":{"lat":48.81091,"lon":14.31521}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Prague","zip":"181 00","country":"Czechia","geoPoint":{"lat":50.08804,"lon":14.42076}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Přerov","zip":"750 02","country":"Czechia","geoPoint":{"lat":49.45511,"lon":17.4509}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Aalborg","zip":"9000","country":"Denmark","geoPoint":{"lat":57.048,"lon":9.9187}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ballerup Municipality","zip":"2750","country":"Denmark","geoPoint":{"lat":55.73165,"lon":12.36328}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Vejle","zip":"7100","country":"Denmark","geoPoint":{"lat":55.70927,"lon":9.5357}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ahmedabad","zip":"380006","country":"India","geoPoint":{"lat":23.02579,"lon":72.58727}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Coimbatore","zip":"641009","country":"India","geoPoint":{"lat":11.00555,"lon":76.96612}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Indore","zip":"452002","country":"India","geoPoint":{"lat":22.71792,"lon":75.8333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Jaipur","zip":"302001","country":"India","geoPoint":{"lat":26.91962,"lon":75.78781}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ludhiana","zip":"141001","country":"India","geoPoint":{"lat":30.91204,"lon":75.85379}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ponce","zip":"00717-2075","country":"Puerto Rico","geoPoint":{"lat":18.01031,"lon":-66.62398}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Rio Piedras","zip":"00921","country":"Puerto Rico","geoPoint":{"lat":18.39745,"lon":-66.04989}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"San Juan","zip":"00917-3104","country":"Puerto Rico","geoPoint":{"lat":18.46633,"lon":-66.10572}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Santurce","zip":"00909","country":"Puerto Rico","geoPoint":{"lat":18.19523,"lon":-67.14018}}]},"referencesModule":{"references":[{"pmid":"36894938","type":"DERIVED","citation":"Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"FG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"FG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"251"},{"groupId":"FG001","numSubjects":"254"},{"groupId":"FG002","numSubjects":"250"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"251"},{"groupId":"FG001","numSubjects":"254"},{"groupId":"FG002","numSubjects":"250"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"199"},{"groupId":"FG001","numSubjects":"225"},{"groupId":"FG002","numSubjects":"206"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"44"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"11"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"13"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"6"}]},{"type":"Entry Criteria Not Met","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Participants who received at least one dose of LY2189265 or Placebo.","groups":[{"id":"BG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"BG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"BG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"251"},{"groupId":"BG001","value":"254"},{"groupId":"BG002","value":"250"},{"groupId":"BG003","value":"755"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.96","spread":"10.14"},{"groupId":"BG001","value":"57.05","spread":"10.17"},{"groupId":"BG002","value":"56.43","spread":"10.50"},{"groupId":"BG003","value":"56.48","spread":"10.27"}]}]}]},{"title":"Sex: Female, 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P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"3.50","ciPctValue":"97.3","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.10","ciUpperLimit":"4.91"},{"groupIds":["OG001","OG002"],"testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"If non-inferiority was confirmed, then superiority analysis was pursued.","pValue":"0.005","pValueComment":"Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.","statisticalMethod":"Mixed Models Analysis","paramType":"Least Squares Mean Difference","paramValue":"1.26","ciPctValue":"97.3","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"2.64"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.996","pValueComment":"Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure","description":"Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"247"},{"groupId":"OG001","value":"251"},{"groupId":"OG002","value":"249"}]}],"classes":[{"title":"Mean 24-Hour PP, Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-3.07","spread":"0.36"},{"groupId":"OG001","value":"-1.60","spread":"0.35"},{"groupId":"OG002","value":"-0.02","spread":"0.36"}]}]},{"title":"Mean 24-Hour PP, Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-2.64","spread":"0.38"},{"groupId":"OG001","value":"-1.53","spread":"0.37"},{"groupId":"OG002","value":"0.46","spread":"0.37"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-3.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.00","ciUpperLimit":"-2.09"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","pValueComment":"Treatment comparison at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-1.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.51","ciUpperLimit":"-0.64"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-3.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.10","ciUpperLimit":"-2.09"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-1.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.98","ciUpperLimit":"-1.00"}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)","description":"Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"247"},{"groupId":"OG001","value":"251"},{"groupId":"OG002","value":"249"}]}],"classes":[{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-1.31","spread":"0.43"},{"groupId":"OG001","value":"-0.65","spread":"0.42"},{"groupId":"OG002","value":"-0.60","spread":"0.42"}]}]},{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-0.74","spread":"0.44"},{"groupId":"OG001","value":"-0.57","spread":"0.42"},{"groupId":"OG002","value":"-0.15","spread":"0.43"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.218","pValueComment":"Treatment comparison at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.71","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.84","ciUpperLimit":"0.42"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.931","pValueComment":"Treatment comparison at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.16","ciUpperLimit":"1.06"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.315","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.72","ciUpperLimit":"0.55"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.465","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.54","ciUpperLimit":"0.70"}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)","description":"Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Mean Daytime SBP, Week 16 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"-3.67","spread":"0.66"},{"groupId":"OG001","value":"-1.57","spread":"0.63"},{"groupId":"OG002","value":"-0.34","spread":"0.64"}]}]},{"title":"Mean Daytime SBP, Week 26 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.52","spread":"0.68"},{"groupId":"OG001","value":"-1.47","spread":"0.65"},{"groupId":"OG002","value":"0.35","spread":"0.67"}]}]},{"title":"Mean Nighttime SBP, Week 16 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.32","spread":"0.76"},{"groupId":"OG001","value":"-1.23","spread":"0.73"},{"groupId":"OG002","value":"-1.08","spread":"0.74"}]}]},{"title":"Mean Nighttime SBP, Week 26 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.40","spread":"0.75"},{"groupId":"OG001","value":"-1.43","spread":"0.72"},{"groupId":"OG002","value":"-0.05","spread":"0.73"}]}]},{"title":"Mean Clinic SBP, Week 16 (n=251, n=254, n=250)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.33","spread":"0.75"},{"groupId":"OG001","value":"-1.26","spread":"0.72"},{"groupId":"OG002","value":"-0.73","spread":"0.73"}]}]},{"title":"Mean Clinic SBP, Week 26 (n=251, n=254, n=250)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.29","spread":"0.77"},{"groupId":"OG001","value":"-0.74","spread":"0.74"},{"groupId":"OG002","value":"0.40","spread":"0.75"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-3.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.04","ciUpperLimit":"-1.61"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.153","pValueComment":"Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-1.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.91","ciUpperLimit":"0.46"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","pValueComment":"Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final 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(SBP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.012","pValueComment":"Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.274","pValueComment":"Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)","description":"Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Mean Daytime DBP, Week 16 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.09","spread":"0.43"},{"groupId":"OG001","value":"0.14","spread":"0.41"},{"groupId":"OG002","value":"-0.30","spread":"0.42"}]}]},{"title":"Mean Daytime DBP, Week 26 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"0.52","spread":"0.43"},{"groupId":"OG001","value":"0.08","spread":"0.41"},{"groupId":"OG002","value":"-0.07","spread":"0.42"}]}]},{"title":"Mean Nighttime DBP, Week 16 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.01","spread":"0.49"},{"groupId":"OG001","value":"-0.28","spread":"0.48"},{"groupId":"OG002","value":"-1.10","spread":"0.48"}]}]},{"title":"Mean Nighttime DBP, Week 26 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.22","spread":"0.51"},{"groupId":"OG001","value":"-0.42","spread":"0.50"},{"groupId":"OG002","value":"-0.69","spread":"0.51"}]}]},{"title":"Mean Clinic DBP, Week 16 (n=251, n=254, n=250)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.21","spread":"0.52"},{"groupId":"OG001","value":"0.76","spread":"0.50"},{"groupId":"OG002","value":"-0.21","spread":"0.51"}]}]},{"title":"Mean Clinic DBP, Week 26 (n=251, n=254, n=250)","categories":[{"measurements":[{"groupId":"OG000","value":"0.59","spread":"0.50"},{"groupId":"OG001","value":"0.69","spread":"0.48"},{"groupId":"OG002","value":"0.61","spread":"0.49"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.717","pValueComment":"Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.91","ciUpperLimit":"1.32"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.427","pValueComment":"Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"0.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.65","ciUpperLimit":"1.54"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.300","pValueComment":"Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final 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(DBP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.972","pValueComment":"Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.904","pValueComment":"Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)","description":"Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats per minute (bpm)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Mean Daytime HR, Week 16 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"3.56","spread":"0.50"},{"groupId":"OG001","value":"2.22","spread":"0.49"},{"groupId":"OG002","value":"1.07","spread":"0.49"}]}]},{"title":"Mean Daytime HR, Week 26 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"4.24","spread":"0.51"},{"groupId":"OG001","value":"1.59","spread":"0.49"},{"groupId":"OG002","value":"0.67","spread":"0.50"}]}]},{"title":"Mean Nighttime HR, Week 16 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"4.60","spread":"0.51"},{"groupId":"OG001","value":"3.43","spread":"0.49"},{"groupId":"OG002","value":"0.65","spread":"0.50"}]}]},{"title":"Mean Nighttime HR, Week 26 (n=247, n=251, n=249)","categories":[{"measurements":[{"groupId":"OG000","value":"4.76","spread":"0.57"},{"groupId":"OG001","value":"3.01","spread":"0.54"},{"groupId":"OG002","value":"0.77","spread":"0.55"}]}]},{"title":"Mean Clinic HR, Week 16 (n=251, n=254, n=250)","categories":[{"measurements":[{"groupId":"OG000","value":"3.97","spread":"0.49"},{"groupId":"OG001","value":"2.11","spread":"0.48"},{"groupId":"OG002","value":"0.46","spread":"0.48"}]}]},{"title":"Mean Clinic HR, Week 26 (n=251, n=254, n=250)","categories":[{"measurements":[{"groupId":"OG000","value":"4.89","spread":"0.54"},{"groupId":"OG001","value":"1.93","spread":"0.52"},{"groupId":"OG002","value":"-0.11","spread":"0.53"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean daytime heart rate (HR) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"2.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.17","ciUpperLimit":"3.80"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.080","pValueComment":"Treatment comparison of mean daytime heart rate (HR) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"1.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.14","ciUpperLimit":"2.45"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean daytime heart rate (HR) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final 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Values)","paramValue":"3.95","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.62","ciUpperLimit":"5.28"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"2.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.47","ciUpperLimit":"4.09"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"3.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.49","ciUpperLimit":"5.47"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","pValueComment":"Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"2.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.78","ciUpperLimit":"3.70"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean clinic heart rate (HR) at 16 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.014","pValueComment":"Treatment comparison of mean clinic heart rate (HR) at 16 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean clinic heart rate (HR) at 26 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","pValueComment":"Treatment comparison of mean clinic heart rate (HR) at 26 weeks.","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure","description":"Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"247"},{"groupId":"OG001","value":"251"},{"groupId":"OG002","value":"249"}]}],"classes":[{"title":"Mean Daytime PP, Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-3.46","spread":"0.40"},{"groupId":"OG001","value":"-1.76","spread":"0.38"},{"groupId":"OG002","value":"0.01","spread":"0.39"}]}]},{"title":"Mean Daytime PP, Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-2.90","spread":"0.42"},{"groupId":"OG001","value":"-1.62","spread":"0.41"},{"groupId":"OG002","value":"0.51","spread":"0.42"}]}]},{"title":"Mean Nighttime PP, Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-2.23","spread":"0.45"},{"groupId":"OG001","value":"-0.92","spread":"0.43"},{"groupId":"OG002","value":"0.02","spread":"0.44"}]}]},{"title":"Mean Nighttime PP, Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-2.09","spread":"0.43"},{"groupId":"OG001","value":"-0.96","spread":"0.41"},{"groupId":"OG002","value":"0.65","spread":"0.42"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-3.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.50","ciUpperLimit":"-2.43"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-1.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.79","ciUpperLimit":"-0.75"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-3.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.52","ciUpperLimit":"-2.28"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final 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and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)","description":"Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeters of mercury (mmHg)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"247"},{"groupId":"OG001","value":"251"},{"groupId":"OG002","value":"249"}]}],"classes":[{"title":"Mean Daytime MAP, Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-1.30","spread":"0.48"},{"groupId":"OG001","value":"-0.42","spread":"0.46"},{"groupId":"OG002","value":"-0.33","spread":"0.47"}]}]},{"title":"Mean Daytime MAP, Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-0.51","spread":"0.49"},{"groupId":"OG001","value":"-0.42","spread":"0.47"},{"groupId":"OG002","value":"0.05","spread":"0.48"}]}]},{"title":"Mean Nighttime MAP, Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-0.80","spread":"0.56"},{"groupId":"OG001","value":"-0.59","spread":"0.53"},{"groupId":"OG002","value":"-1.11","spread":"0.54"}]}]},{"title":"Mean Nighttime MAP, Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-0.96","spread":"0.57"},{"groupId":"OG001","value":"-0.76","spread":"0.54"},{"groupId":"OG002","value":"-0.50","spread":"0.56"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.128","pValueComment":"Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.22","ciUpperLimit":"0.28"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.883","pValueComment":"Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.32","ciUpperLimit":"1.13"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.390","pValueComment":"Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.84","ciUpperLimit":"0.72"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.463","pValueComment":"Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"-0.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.72","ciUpperLimit":"0.79"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.671","pValueComment":"Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final Values)","paramValue":"0.31","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.13","ciUpperLimit":"1.76"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.471","pValueComment":"Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.","statisticalMethod":"Mixed Models Analysis","paramType":"Mean Difference (Final 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Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)","description":"Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of HbA1c","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-1.18","spread":"0.06"},{"groupId":"OG001","value":"-1.04","spread":"0.05"},{"groupId":"OG002","value":"-0.06","spread":"0.05"}]}]},{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-1.01","spread":"0.07"},{"groupId":"OG001","value":"-0.89","spread":"0.06"},{"groupId":"OG002","value":"-0.02","spread":"0.06"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)","description":"Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"247"},{"groupId":"OG002","value":"249"}]}],"classes":[{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-2.05","spread":"0.13"},{"groupId":"OG001","value":"-1.94","spread":"0.13"},{"groupId":"OG002","value":"-0.30","spread":"0.13"}]}]},{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-1.67","spread":"0.15"},{"groupId":"OG001","value":"-1.66","spread":"0.15"},{"groupId":"OG002","value":"0.00","spread":"0.15"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%","description":"Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of \\<7% or ≤6.5% were analyzed with Chi-squared test/Fisher's exact test.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline and 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"HbA1c levels <7.0%, Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"6.8"},{"groupId":"OG001","value":"6.7"},{"groupId":"OG002","value":"8.0"}]}]},{"title":"HbA1c levels ≤6.5%, Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.4"},{"groupId":"OG002","value":"0.4"}]}]},{"title":"HbA1c levels <7.0%, Week 16 (n=216, n=234, n=225)","categories":[{"measurements":[{"groupId":"OG000","value":"66.7"},{"groupId":"OG001","value":"59.0"},{"groupId":"OG002","value":"12.9"}]}]},{"title":"HbA1c levels ≤6.5%, Week 16 (n=216, n=234, n=225)","categories":[{"measurements":[{"groupId":"OG000","value":"45.8"},{"groupId":"OG001","value":"36.8"},{"groupId":"OG002","value":"6.2"}]}]},{"title":"HbA1c levels <7.0%, Week 26 (n=206, n=226, n=210)","categories":[{"measurements":[{"groupId":"OG000","value":"62.1"},{"groupId":"OG001","value":"54.9"},{"groupId":"OG002","value":"14.3"}]}]},{"title":"HbA1c levels ≤6.5%, Week 26 (n=206, n=226, n=210)","categories":[{"measurements":[{"groupId":"OG000","value":"38.8"},{"groupId":"OG001","value":"35.8"},{"groupId":"OG002","value":"5.2"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Treatment Emergent Adverse Events at 26 Weeks","description":"A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"156"},{"groupId":"OG002","value":"162"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes","description":"Amylase (total and pancreas-derived) and lipase concentrations were measured.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable pancreatic enzyme data.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"units per liter","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"227"},{"groupId":"OG002","value":"224"}]}],"classes":[{"title":"Amylase, Total, Week 16 (n=214, 227, 224)","categories":[{"measurements":[{"groupId":"OG000","value":"6.00","lowerLimit":"-2.00","upperLimit":"13.00"},{"groupId":"OG001","value":"5.00","lowerLimit":"-3.00","upperLimit":"14.00"},{"groupId":"OG002","value":"0.00","lowerLimit":"-6.00","upperLimit":"7.00"}]}]},{"title":"Amylase, Total, Week 26 (n=205, 220, 209)","categories":[{"measurements":[{"groupId":"OG000","value":"7.00","lowerLimit":"-2.00","upperLimit":"16.00"},{"groupId":"OG001","value":"4.00","lowerLimit":"-2.00","upperLimit":"15.50"},{"groupId":"OG002","value":"0.00","lowerLimit":"-5.00","upperLimit":"6.00"}]}]},{"title":"Amylase, Pancreas-derived, Wk 16 (n=213, 227, 224)","categories":[{"measurements":[{"groupId":"OG000","value":"4.00","lowerLimit":"0.00","upperLimit":"9.00"},{"groupId":"OG001","value":"3.00","lowerLimit":"-1.00","upperLimit":"9.00"},{"groupId":"OG002","value":"1.00","lowerLimit":"-3.50","upperLimit":"4.00"}]}]},{"title":"Amylase, Pancreas-derived, Wk 26 (n=204, 220, 209)","categories":[{"measurements":[{"groupId":"OG000","value":"5.00","lowerLimit":"1.00","upperLimit":"10.00"},{"groupId":"OG001","value":"3.50","lowerLimit":"0.00","upperLimit":"9.50"},{"groupId":"OG002","value":"1.00","lowerLimit":"-3.00","upperLimit":"4.00"}]}]},{"title":"Lipase, Week 16 (n=214, 227, 224)","categories":[{"measurements":[{"groupId":"OG000","value":"4.00","lowerLimit":"-2.00","upperLimit":"14.00"},{"groupId":"OG001","value":"3.00","lowerLimit":"-4.00","upperLimit":"12.00"},{"groupId":"OG002","value":"-1.00","lowerLimit":"-7.00","upperLimit":"6.00"}]}]},{"title":"Lipase, Week 26 (n=205, 220, 209)","categories":[{"measurements":[{"groupId":"OG000","value":"6.00","lowerLimit":"-1.00","upperLimit":"14.00"},{"groupId":"OG001","value":"5.00","lowerLimit":"-3.00","upperLimit":"13.00"},{"groupId":"OG002","value":"0.00","lowerLimit":"-6.00","upperLimit":"5.00"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks on Serum Calcitonin","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable serum calcitonin data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"picograms per milliliter (pg/mL)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"213"},{"groupId":"OG001","value":"223"},{"groupId":"OG002","value":"223"}]}],"classes":[{"title":"Week 16 (n=213, n=223, n=223)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.30","spread":"1.87"},{"groupId":"OG001","value":"-0.03","spread":"1.81"},{"groupId":"OG002","value":"-0.39","spread":"1.24"}]}]},{"title":"Week 26 (n=202, n=220, n=209)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.19","spread":"1.73"},{"groupId":"OG001","value":"0.02","spread":"2.04"},{"groupId":"OG002","value":"-0.05","spread":"2.38"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable High-Sensitivity C-Reactive Protein (hs-CRP) data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milligram per liter (mg/L)","timeFrame":"Baseline, 16 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"228"},{"groupId":"OG002","value":"224"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.79","spread":"4.91","lowerLimit":"-1.27","upperLimit":"0.14"},{"groupId":"OG001","value":"-0.20","spread":"7.96","lowerLimit":"-1.05","upperLimit":"0.75"},{"groupId":"OG002","value":"0.29","spread":"6.73","lowerLimit":"-1.13","upperLimit":"0.02"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval","description":"The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable Fridericia-corrected QT (QTcF) or PR interval change from baseline data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milliseconds (msec)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"250"},{"groupId":"OG002","value":"246"}]}],"classes":[{"title":"QTcF Interval, Week 16 (n=248, n=250, n=246)","categories":[{"measurements":[{"groupId":"OG000","value":"-2.31","spread":"0.97"},{"groupId":"OG001","value":"-0.96","spread":"0.91"},{"groupId":"OG002","value":"1.06","spread":"0.93"}]}]},{"title":"QTcF Interval, Week 26 (n=248, n=250, n=246)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.73","spread":"0.96"},{"groupId":"OG001","value":"-0.93","spread":"0.92"},{"groupId":"OG002","value":"1.26","spread":"0.94"}]}]},{"title":"PR Interval, Week 16 (n=248, n=250, n=244)","categories":[{"measurements":[{"groupId":"OG000","value":"4.96","spread":"0.98"},{"groupId":"OG001","value":"3.67","spread":"0.92"},{"groupId":"OG002","value":"0.01","spread":"0.95"}]}]},{"title":"PR Interval, Week 26 (n=248, n=250, n=244)","categories":[{"measurements":[{"groupId":"OG000","value":"3.32","spread":"0.86"},{"groupId":"OG001","value":"3.17","spread":"0.81"},{"groupId":"OG002","value":"-1.98","spread":"0.84"}]}]}]},{"type":"SECONDARY","title":"Number of Events of Adjudicated Pancreatitis up to 26 Weeks","description":"The number of adjudicated (by an independent Clinical Endpoint Committee \\[CEC\\]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"events","timeFrame":"Baseline through 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks","description":"Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline through 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Any cardiovascular event","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}]},{"title":"Any fatal cardiovascular event","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Any non-fatal cardiovascular event","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}]}]},{"type":"SECONDARY","title":"Anti-LY2189265 Antibodies","description":"LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 16 and 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (30 weeks). The number of participants with initial postbaseline detection of treatment-emergent (defined as a 4-fold increase in the ADA titer from baseline) anti-drug (LY2189265) ADA at each time point were summarized.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable anti-drug (LY2189265) antibodies (ADA) data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline, 16, 26, and 30 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}]},{"title":"Week 30","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Rate of Hypoglycemic Episodes","description":"Hypoglycemic events (HE) were classified as severe (defined as an HE requiring assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter \\[mmol/L\\]), asymptomatic (defined as an HE without typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), nocturnal (defined as any HE occurring between bedtime and waking with a measured blood glucose of ≤3.9 mmol/L), or non-nocturnal. Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Logit link. Negative binomial mean was adjusted by treatment, visit, and visit by treatment interaction. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"events per participant per 30 days","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Severe","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"0","spread":"0"},{"groupId":"OG002","value":"0","spread":"0"}]}]},{"title":"Documented Symptomatic","categories":[{"measurements":[{"groupId":"OG000","value":"0.14","spread":"0.43"},{"groupId":"OG001","value":"0.16","spread":"0.59"},{"groupId":"OG002","value":"0.08","spread":"0.39"}]}]},{"title":"Asymptomatic","categories":[{"measurements":[{"groupId":"OG000","value":"0.17","spread":"0.89"},{"groupId":"OG001","value":"0.15","spread":"0.59"},{"groupId":"OG002","value":"0.06","spread":"0.25"}]}]},{"title":"Nocturnal","categories":[{"measurements":[{"groupId":"OG000","value":"0.06","spread":"0.30"},{"groupId":"OG001","value":"0.12","spread":"0.64"},{"groupId":"OG002","value":"0.03","spread":"0.22"}]}]},{"title":"Non-nocturnal","categories":[{"measurements":[{"groupId":"OG000","value":"0.29","spread":"0.97"},{"groupId":"OG001","value":"0.26","spread":"0.70"},{"groupId":"OG002","value":"0.15","spread":"0.44"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 16 and 26 Weeks in Body Weight","description":"Least Squares (LS) means was calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilogram (kg)","timeFrame":"Baseline, 16 and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"254"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"-1.84","spread":"0.18"},{"groupId":"OG001","value":"-0.83","spread":"0.18"},{"groupId":"OG002","value":"-0.13","spread":"0.18"}]}]},{"title":"Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-1.85","spread":"0.23"},{"groupId":"OG001","value":"-0.86","spread":"0.22"},{"groupId":"OG002","value":"-0.08","spread":"0.22"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 16 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","pValueComment":"Treatment comparison at 16 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.012","pValueComment":"Treatment comparison at 26 weeks.","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)","description":"The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve \\[AUC\\] at steady state from time zero to 168 hours after study drug administration). Evaluable pharmacokinetic concentrations from the 4, 8, 12, 16, and 26 weeks timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.","populationDescription":"Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"nanograms*hour per liter (ng*h/L)","timeFrame":"4, 8, 12, 16, and 26 weeks","groups":[{"id":"OG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"},{"id":"OG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"235"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11208","spread":"3744"},{"groupId":"OG001","value":"5998","spread":"2003"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"4","eventGroups":[{"id":"EG000","title":"1.5 Milligram (mg) LY2189265","description":"LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks","seriousNumAffected":12,"seriousNumAtRisk":251,"otherNumAffected":164,"otherNumAtRisk":251},{"id":"EG001","title":"0.75 Milligram (mg) LY2189265","description":"LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks","seriousNumAffected":8,"seriousNumAtRisk":254,"otherNumAffected":161,"otherNumAtRisk":254},{"id":"EG002","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks","seriousNumAffected":8,"seriousNumAtRisk":250,"otherNumAffected":163,"otherNumAtRisk":250}],"seriousEvents":[{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":254},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Ventricular tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":254},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Abdominal pain lower","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":254},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Barrett's oesophagus","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":254},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Gastrooesophageal reflux disease","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":254},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":254},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":254},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Granuloma","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":254},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Non-cardiac chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":254},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Cholelithiasis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 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