{"protocolSection":{"identificationModule":{"nctId":"NCT00630825","orgStudyIdInfo":{"id":"12068"},"secondaryIdInfos":[{"id":"H9X-MC-GBCJ","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus","officialTitle":"The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus","acronym":"EGO"},"statusModule":{"statusVerifiedDate":"2014-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-04"},"primaryCompletionDateStruct":{"date":"2009-01","type":"ACTUAL"},"completionDateStruct":{"date":"2009-01","type":"ACTUAL"},"studyFirstSubmitDate":"2008-02-28","studyFirstSubmitQcDate":"2008-02-28","studyFirstPostDateStruct":{"date":"2008-03-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-10-03","resultsFirstSubmitQcDate":"2014-12-08","resultsFirstPostDateStruct":{"date":"2014-12-10","type":"ESTIMATED"},"dispFirstSubmitDate":"2009-12-09","dispFirstSubmitQcDate":"2009-12-09","dispFirstPostDateStruct":{"date":"2009-12-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-12-08","lastUpdatePostDateStruct":{"date":"2014-12-10","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants."},"conditionsModule":{"conditions":["Diabetes Mellitus Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":262,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"1.0/2.0 milligram (mg) LY2189265","type":"EXPERIMENTAL","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks","interventionNames":["Drug: LY2189265"]},{"label":"1.0/1.0 milligram (mg) LY2189265","type":"EXPERIMENTAL","description":"LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks","interventionNames":["Drug: LY2189265"]},{"label":"0.5/1.0 milligram (mg) LY2189265","type":"EXPERIMENTAL","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks","interventionNames":["Drug: LY2189265"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"LY2189265","armGroupLabels":["0.5/1.0 milligram (mg) LY2189265","1.0/1.0 milligram (mg) LY2189265","1.0/2.0 milligram (mg) LY2189265"],"otherNames":["Dulaglutide"]},{"type":"DRUG","name":"Placebo","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus","description":"Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).","timeFrame":"Baseline, 16 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Fasting Blood Glucose","description":"Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.","timeFrame":"Baseline, 16 weeks"},{"measure":"Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)","description":"Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie \\[Kcal\\], 103 grams \\[g\\] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting \\[0\\]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.","timeFrame":"Baseline and 16 weeks"},{"measure":"Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles","description":"Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.","timeFrame":"2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits."},{"measure":"Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)","description":"Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.","timeFrame":"Baseline, 16 weeks"},{"measure":"Percentage of Participants Achieving a 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 a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.","timeFrame":"Baseline and 4 and 8 and 16 weeks"},{"measure":"Change From Baseline in Body Weight","description":"LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.","timeFrame":"Baseline, 4, 8, and 16 weeks"},{"measure":"Change From Baseline in Waist Circumference","description":"Mean change from baseline in waist circumference (a measure of central obesity).","timeFrame":"Baseline, 16 weeks"},{"measure":"Nausea and Dyspepsia Measured by Visual Analog Scale","description":"Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.","timeFrame":"One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits"},{"measure":"Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores","description":"Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.","timeFrame":"Baseline and 4 and 8 and 16 weeks"},{"measure":"Number of Participants With a Hypoglycemic Event","description":"A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \\[mmol/L\\]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of \\<50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 4, 8, and 16 weeks"},{"measure":"Rate of Hypoglycemia Per 30 Days","description":"Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \\[mmol/L\\]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","timeFrame":"Baseline through 16 weeks"},{"measure":"Change From Baseline in Lipids","description":"Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.","timeFrame":"Baseline, 16 weeks"},{"measure":"Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire","description":"The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6-point scale ranging from 1 \"completely dissatisfied\" to 6 \"completely satisfied\"; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 \"all of the time\" to 4 \"none of the time\"; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 \"all of the time\" to 4 \"none of the time.\" These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized.","timeFrame":"Baseline and 4 and 8 and 16 weeks"},{"measure":"Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire","description":"This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.","timeFrame":"Baseline and 4 and 8 and 16 weeks"},{"measure":"Pharmacokinetics (PK) of LY2189265 - 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).","timeFrame":"Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus \\>3 months by history prior to entering the trial, based on disease diagnostic criteria from the American Diabetes Association (ADA 2007).\n* Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.\n* Have glycosylated hemoglobin (HbA1c) of \\>7.0% to ≤10.5% as determined by central laboratory at screening.\n* Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m\\^2), inclusive.\n* Have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4 (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).\n\nExclusion Criteria:\n\n* Have known Type 1 Diabetes Mellitus\n* Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)\n* Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty \\[PTCA\\], open heart surgery, or coronary artery bypass graft \\[CABG\\]), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to screening.\n* Have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) \\>2 milligrams per deciliter (mg/dL). If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be ≤1.5 mg/dL.\n* Currently taking prescription or over the counter medications to prevent weight loss.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM 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":"Peoria","state":"Arizona","zip":"85381","country":"United States","geoPoint":{"lat":33.5806,"lon":-112.23738}},{"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":"92805","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":"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":"Northridge","state":"California","zip":"91326","country":"United States","geoPoint":{"lat":34.22834,"lon":-118.53675}},{"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":"Palm Springs","state":"California","zip":"92262","country":"United States","geoPoint":{"lat":33.8303,"lon":-116.54529}},{"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":"South Miami","state":"Florida","zip":"33143","country":"United States","geoPoint":{"lat":25.7076,"lon":-80.29338}},{"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":"West Palm Beach","state":"Florida","zip":"33401","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"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":"Athens","state":"Georgia","zip":"30606","country":"United States","geoPoint":{"lat":33.96095,"lon":-83.37794}},{"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":"Atlanta","state":"Georgia","zip":"30303","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"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":"Illinois","zip":"62704","country":"United States","geoPoint":{"lat":39.80172,"lon":-89.64371}},{"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":"46250","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":"Biddeford","state":"Maine","zip":"04005","country":"United States","geoPoint":{"lat":43.49258,"lon":-70.45338}},{"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":"Ann Arbor","state":"Michigan","zip":"48108","country":"United States","geoPoint":{"lat":42.27756,"lon":-83.74088}},{"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":"Bloomfield Hills","state":"Michigan","zip":"48302","country":"United States","geoPoint":{"lat":42.58364,"lon":-83.24549}},{"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":"Billings","state":"Montana","zip":"59101","country":"United States","geoPoint":{"lat":45.78329,"lon":-108.50069}},{"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":"Flemington","state":"New Jersey","zip":"08822","country":"United States","geoPoint":{"lat":40.51233,"lon":-74.85933}},{"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":"Syracuse","state":"New York","zip":"13210","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}},{"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":"Greensboro","state":"North Carolina","zip":"27401","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"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":"Greenville","state":"North Carolina","zip":"27834","country":"United States","geoPoint":{"lat":35.61266,"lon":-77.36635}},{"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":"Morehead City","state":"North Carolina","zip":"28557","country":"United States","geoPoint":{"lat":34.72294,"lon":-76.72604}},{"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":"Memphis","state":"Tennessee","zip":"38119","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"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":"78731","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":"Dallas","state":"Texas","zip":"75230","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"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 Antonio","state":"Texas","zip":"78237","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}},{"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":"Norfolk","state":"Virginia","zip":"23510","country":"United States","geoPoint":{"lat":36.84681,"lon":-76.28522}},{"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":"Spokane","state":"Washington","zip":"99216","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}},{"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":"Tacoma","state":"Washington","zip":"98405","country":"United States","geoPoint":{"lat":47.25288,"lon":-122.44429}},{"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":"Wenatchee","state":"Washington","zip":"98801","country":"United States","geoPoint":{"lat":47.42346,"lon":-120.31035}},{"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":"Menomonee Falls","state":"Wisconsin","zip":"53051","country":"United States","geoPoint":{"lat":43.1789,"lon":-88.11731}},{"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":"Manati","zip":"00674","country":"Puerto Rico","geoPoint":{"lat":18.42745,"lon":-66.49212}},{"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":"00907","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":"Toa Baja","zip":"00949","country":"Puerto Rico","geoPoint":{"lat":18.44384,"lon":-66.25961}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Lilly Clinical Trial Registry","url":"http://www.lillytrials.com"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"FG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"FG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"FG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"65"},{"groupId":"FG001","numSubjects":"65"},{"groupId":"FG002","numSubjects":"66"},{"groupId":"FG003","numSubjects":"66"}]},{"type":"Received at Least One Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"65"},{"groupId":"FG001","numSubjects":"65"},{"groupId":"FG002","numSubjects":"66"},{"groupId":"FG003","numSubjects":"66"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"56"},{"groupId":"FG001","numSubjects":"58"},{"groupId":"FG002","numSubjects":"58"},{"groupId":"FG003","numSubjects":"60"}]},{"type":"NOT 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Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of glycosylated hemoglobin","timeFrame":"Baseline, 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"65"},{"groupId":"OG003","value":"65"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.52","spread":"0.12"},{"groupId":"OG001","value":"-1.29","spread":"0.12"},{"groupId":"OG002","value":"-1.28","spread":"0.12"},{"groupId":"OG003","value":"-0.27","spread":"0.12"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-values ≤0.05 were considered significant. 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If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline, 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.64","spread":"0.33"},{"groupId":"OG001","value":"-2.04","spread":"0.34"},{"groupId":"OG002","value":"-2.09","spread":"0.34"},{"groupId":"OG003","value":"-0.49","spread":"0.32"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"}]},{"type":"SECONDARY","title":"Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)","description":"Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie \\[Kcal\\], 103 grams \\[g\\] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting \\[0\\]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable glucose excursion data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimoles per liter (mmol/L)*minute","timeFrame":"Baseline and 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"54"},{"groupId":"OG003","value":"59"}]}],"classes":[{"title":"Baseline (n=63, n=62, n=66, n=63)","categories":[{"measurements":[{"groupId":"OG000","value":"11.03","spread":"5.02"},{"groupId":"OG001","value":"11.12","spread":"4.77"},{"groupId":"OG002","value":"10.32","spread":"4.93"},{"groupId":"OG003","value":"10.76","spread":"4.37"}]}]},{"title":"Week 16 (n=52, n=56, n=54, n=59)","categories":[{"measurements":[{"groupId":"OG000","value":"8.16","spread":"4.58"},{"groupId":"OG001","value":"9.92","spread":"5.32"},{"groupId":"OG002","value":"8.85","spread":"4.94"},{"groupId":"OG003","value":"10.94","spread":"4.79"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.047","pValueComment":"Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.025","pValueComment":"Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"}]},{"type":"SECONDARY","title":"Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles","description":"Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable blood glucose (SMBG) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"milligrams per deciliter (mg/dL)","timeFrame":"2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"49"}]}],"classes":[{"title":"Week 4 (n=34, n=38, n=35, n=41)","categories":[{"measurements":[{"groupId":"OG000","value":"-31.19","spread":"5.85"},{"groupId":"OG001","value":"-35.94","spread":"5.30"},{"groupId":"OG002","value":"-31.66","spread":"5.36"},{"groupId":"OG003","value":"-8.10","spread":"5.06"}]}]},{"title":"Week 8 (n=34, n=41, n=38, n=41)","categories":[{"measurements":[{"groupId":"OG000","value":"-43.00","spread":"5.88"},{"groupId":"OG001","value":"-40.68","spread":"5.43"},{"groupId":"OG002","value":"-36.02","spread":"5.35"},{"groupId":"OG003","value":"-14.58","spread":"5.38"}]}]},{"title":"Week 16 (n=41, n=50, n=46, n=49)","categories":[{"measurements":[{"groupId":"OG000","value":"-37.49","spread":"5.89"},{"groupId":"OG001","value":"-41.79","spread":"5.25"},{"groupId":"OG002","value":"-32.52","spread":"5.40"},{"groupId":"OG003","value":"-8.67","spread":"5.30"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG000","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"}]},{"type":"SECONDARY","title":"Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)","description":"Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. 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No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"},{"groupIds":["OG001","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.138","statisticalMethod":"ANCOVA","statisticalComment":"Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed."},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.729","pValueComment":"Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. 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For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. 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No adjustment for multiple comparisons was performed.","statisticalMethod":"ANCOVA"}]},{"type":"SECONDARY","title":"Nausea and Dyspepsia Measured by Visual Analog Scale","description":"Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable nausea or dyspepsia (abdominal pain and bloating) data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) 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54)","categories":[{"measurements":[{"groupId":"OG000","value":"12.57","spread":"18.93"},{"groupId":"OG001","value":"9.06","spread":"16.78"},{"groupId":"OG002","value":"12.26","spread":"20.06"},{"groupId":"OG003","value":"9.30","spread":"18.60"}]}]},{"title":"Bloating, Week after Week 16 (n=45, 48, 49, 53)","categories":[{"measurements":[{"groupId":"OG000","value":"14.06","spread":"20.46"},{"groupId":"OG001","value":"11.11","spread":"19.62"},{"groupId":"OG002","value":"14.04","spread":"22.26"},{"groupId":"OG003","value":"8.84","spread":"17.44"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores","description":"Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable Gastroparesis Cardinal Symptom Index (GCSI) questionnaire data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 4 and 8 and 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"classes":[{"title":"Stomach fullness, Week 4 (n=62, n=60, n=65, n=65)","categories":[{"measurements":[{"groupId":"OG000","value":"0.55","spread":"1.51"},{"groupId":"OG001","value":"0.57","spread":"1.35"},{"groupId":"OG002","value":"0.62","spread":"1.26"},{"groupId":"OG003","value":"0.35","spread":"1.39"}]}]},{"title":"Stomach fullness, Week 8 (n=59, n=60, n=59, n=63)","categories":[{"measurements":[{"groupId":"OG000","value":"0.46","spread":"1.65"},{"groupId":"OG001","value":"0.30","spread":"1.33"},{"groupId":"OG002","value":"0.71","spread":"1.54"},{"groupId":"OG003","value":"0.25","spread":"1.39"}]}]},{"title":"Stomach fullness, Week 16 (n=63, n=62, n=65, n=65)","categories":[{"measurements":[{"groupId":"OG000","value":"0.21","spread":"1.58"},{"groupId":"OG001","value":"0.27","spread":"1.28"},{"groupId":"OG002","value":"0.51","spread":"1.34"},{"groupId":"OG003","value":"0.15","spread":"1.34"}]}]},{"title":"Bloating, Week 4 (n=62, n=60, n=65, n=65)","categories":[{"measurements":[{"groupId":"OG000","value":"0.35","spread":"0.10"},{"groupId":"OG001","value":"0.28","spread":"0.93"},{"groupId":"OG002","value":"0.19","spread":"0.91"},{"groupId":"OG003","value":"0.28","spread":"0.84"}]}]},{"title":"Bloating, Week 8 (n=59, n=60, n=60, n=63)","categories":[{"measurements":[{"groupId":"OG000","value":"0.41","spread":"1.34"},{"groupId":"OG001","value":"0.13","spread":"1.02"},{"groupId":"OG002","value":"0.14","spread":"1.32"},{"groupId":"OG003","value":"0.18","spread":"0.92"}]}]},{"title":"Bloating, Week 16 (n=63, n=62, n=65, n=65)","categories":[{"measurements":[{"groupId":"OG000","value":"0.02","spread":"1.04"},{"groupId":"OG001","value":"0.11","spread":"0.94"},{"groupId":"OG002","value":"0.32","spread":"1.32"},{"groupId":"OG003","value":"0.28","spread":"0.86"}]}]},{"title":"Nausea/Vomiting, Week 4 (n=62, n=60, n=64, n=65)","categories":[{"measurements":[{"groupId":"OG000","value":"0.25","spread":"0.71"},{"groupId":"OG001","value":"0.19","spread":"0.71"},{"groupId":"OG002","value":"0.22","spread":"0.52"},{"groupId":"OG003","value":"0.03","spread":"0.40"}]}]},{"title":"Nausea/Vomiting, Week 8 (n=59, n=60, n=60, n=63)","categories":[{"measurements":[{"groupId":"OG000","value":"0.46","spread":"0.97"},{"groupId":"OG001","value":"0.04","spread":"0.64"},{"groupId":"OG002","value":"0.28","spread":"0.62"},{"groupId":"OG003","value":"0.02","spread":"0.39"}]}]},{"title":"Nausea/Vomiting, Week 16 (n=63, n=62, n=65, n=65)","categories":[{"measurements":[{"groupId":"OG000","value":"0.20","spread":"0.64"},{"groupId":"OG001","value":"-0.01","spread":"0.59"},{"groupId":"OG002","value":"0.27","spread":"0.48"},{"groupId":"OG003","value":"-0.01","spread":"0.36"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With a Hypoglycemic Event","description":"A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \\[mmol/L\\]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of \\<50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. 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 4, 8, and 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"classes":[{"title":"Documented Hypoglycemic Event, Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"9"}]}]},{"title":"Documented Hypoglycemic Event, Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"10"}]}]},{"title":"Documented Hypoglycemic Event, Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"}]}]},{"title":"Severe Hypoglycemic Event, Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Severe Hypoglycemic Event, Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Severe Hypoglycemic Event, Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Rate of Hypoglycemia Per 30 Days","description":"Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \\[mmol/L\\]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. 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 through 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.69","spread":"1.29"},{"groupId":"OG001","value":"0.80","spread":"1.60"},{"groupId":"OG002","value":"0.70","spread":"1.18"},{"groupId":"OG003","value":"0.24","spread":"0.54"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Lipids","description":"Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.","populationDescription":"Participants who received at least one dose of LY2189265 or Placebo with evaluable lipid data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"millimoles per liter (mmol/L)","timeFrame":"Baseline, 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"66"}]}],"classes":[{"title":"Cholesterol (n=61, n=60, n=60, n=62)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.34","lowerLimit":"-3.44","upperLimit":"2.28"},{"groupId":"OG001","value":"-0.05","lowerLimit":"-1.37","upperLimit":"2.69"},{"groupId":"OG002","value":"-0.09","lowerLimit":"-2.18","upperLimit":"4.77"},{"groupId":"OG003","value":"0.18","lowerLimit":"-1.91","upperLimit":"2.56"}]}]},{"title":"LDL-Cholesterol (n=61, n=60, n=60, n=61)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.26","lowerLimit":"-2.80","upperLimit":"2.23"},{"groupId":"OG001","value":"-0.09","lowerLimit":"-1.22","upperLimit":"1.58"},{"groupId":"OG002","value":"-0.07","lowerLimit":"-1.39","upperLimit":"4.27"},{"groupId":"OG003","value":"0.10","lowerLimit":"-0.83","upperLimit":"2.12"}]}]},{"title":"HDL-Cholesterol (n=61, n=60, n=60, n=61)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","lowerLimit":"-0.33","upperLimit":"0.41"},{"groupId":"OG001","value":"-0.02","lowerLimit":"-0.37","upperLimit":"0.54"},{"groupId":"OG002","value":"0.00","lowerLimit":"-0.26","upperLimit":"0.23"},{"groupId":"OG003","value":"0.00","lowerLimit":"-0.24","upperLimit":"0.26"}]}]},{"title":"Triglycerides (n=61, n=60, n=60, n=61)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.16","lowerLimit":"-7.63","upperLimit":"2.22"},{"groupId":"OG001","value":"-0.02","lowerLimit":"-4.84","upperLimit":"2.96"},{"groupId":"OG002","value":"-0.16","lowerLimit":"-4.25","upperLimit":"2.96"},{"groupId":"OG003","value":"0.00","lowerLimit":"-7.39","upperLimit":"5.69"}]}]}]},{"type":"SECONDARY","title":"Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire","description":"The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6-point scale ranging from 1 \"completely dissatisfied\" to 6 \"completely satisfied\"; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 \"all of the time\" to 4 \"none of the time\"; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 \"all of the time\" to 4 \"none of the time.\" These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized.","populationDescription":"Participants in the per-protocol population with evaluable PAM-D-S questionnaire data. The per-protocol population consisted of participants who received at least one dose of study medication, had no significant protocol violations, completed the double-blind treatment phase, and were compliant with the study drug.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline and 4 and 8 and 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"59"},{"groupId":"OG003","value":"58"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"72.7"},{"groupId":"OG001","value":"87.0"},{"groupId":"OG002","value":"87.5"},{"groupId":"OG003","value":"89.1"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"83.3"},{"groupId":"OG001","value":"90.2"},{"groupId":"OG002","value":"87.5"},{"groupId":"OG003","value":"87.0"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"82.9"},{"groupId":"OG001","value":"90.5"},{"groupId":"OG002","value":"90.9"},{"groupId":"OG003","value":"88.6"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"92.1"},{"groupId":"OG001","value":"90.2"},{"groupId":"OG002","value":"86.0"},{"groupId":"OG003","value":"93.0"}]}]}]},{"type":"SECONDARY","title":"Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire","description":"This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.","populationDescription":"The items in the Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. Therefore, no participants were analyzed for validation purposes.","reportingStatus":"POSTED","timeFrame":"Baseline and 4 and 8 and 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks"},{"id":"OG001","title":"1.0/1.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks"},{"id":"OG002","title":"0.5/1.0 Milligram (mg) LY2189265","description":"LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks"},{"id":"OG003","title":"Placebo","description":"Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"type":"SECONDARY","title":"Pharmacokinetics (PK) of LY2189265 - 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).","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/milliliter (ng*h/mL)","timeFrame":"Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks","groups":[{"id":"OG000","title":"1.0/2.0 Milligram (mg) LY2189265","description":"LY2189265: 1.0 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weeks","seriousNumAffected":1,"seriousNumAtRisk":66,"otherNumAffected":36,"otherNumAtRisk":66}],"seriousEvents":[{"term":"Pancreatitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66}]},{"term":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66}]},{"term":"Septic shock","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":66}]},{"term":"Osteoarthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":2,"numAffected":1,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66}]},{"term":"Colon cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 11.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":65},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":66},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66}]},{"term":"Hallucination","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66}]},{"term":"Cryptogenic organising pneumonia","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 11.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":65},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":66},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":66}]}],"otherEvents":[{"term":"Abdominal distension","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.0","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":65},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":65},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":66},{"groupId":"EG003","numEvents":4,"numAffected":4,"numAtRisk":66}]},{"term":"Abdominal pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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