{"protocolSection":{"identificationModule":{"nctId":"NCT01300260","orgStudyIdInfo":{"id":"11371"},"secondaryIdInfos":[{"id":"H9X-MC-GBCI","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose","officialTitle":"The Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose Infusion"},"statusModule":{"statusVerifiedDate":"2014-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-02"},"primaryCompletionDateStruct":{"date":"2011-08","type":"ACTUAL"},"completionDateStruct":{"date":"2011-08","type":"ACTUAL"},"studyFirstSubmitDate":"2011-02-03","studyFirstSubmitQcDate":"2011-02-18","studyFirstPostDateStruct":{"date":"2011-02-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-10-03","resultsFirstSubmitQcDate":"2014-10-03","resultsFirstPostDateStruct":{"date":"2014-10-07","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-10-03","lastUpdatePostDateStruct":{"date":"2014-10-07","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 measure the effect of LY2189265 to increase insulin levels in response to glucose intake."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":32,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"LY2189265 then Placebo","type":"EXPERIMENTAL","description":"LY2189265 (Dulaglutide) then Placebo: A single 1.5 milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 in Period 1, followed by a single SC injection of Placebo on Day 1 in Period 2.\n\nOn Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.\n\nThere was a washout period of at least 28 days between Periods 1 and 2.","interventionNames":["Biological: LY2189265","Drug: Placebo","Drug: Insulin","Drug: Glucose","Drug: Glucagon"]},{"label":"Placebo then LY2189265","type":"EXPERIMENTAL","description":"Placebo then LY2189265 (Dulaglutide): A single subcutaneous injection of Placebo on Day 1 in Period 1, followed by a single 1.5 milligrams (mg) subcutaneous injection of LY2189265 on Day 1 in Period 2.\n\nOn Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.\n\nThere was a washout period of at least 28 days between Periods 1 and 2.","interventionNames":["Biological: LY2189265","Drug: Placebo","Drug: Insulin","Drug: Glucose","Drug: Glucagon"]}],"interventions":[{"type":"BIOLOGICAL","name":"LY2189265","description":"Administered subcutaneously","armGroupLabels":["LY2189265 then Placebo","Placebo then LY2189265"],"otherNames":["Dulaglutide"]},{"type":"DRUG","name":"Placebo","description":"Administered subcutaneously","armGroupLabels":["LY2189265 then Placebo","Placebo then LY2189265"]},{"type":"DRUG","name":"Insulin","description":"Administered intravenously","armGroupLabels":["LY2189265 then Placebo","Placebo then LY2189265"],"otherNames":["Lispro"]},{"type":"DRUG","name":"Glucose","description":"Administered intravenously","armGroupLabels":["LY2189265 then Placebo","Placebo then LY2189265"],"otherNames":["Dextrose"]},{"type":"DRUG","name":"Glucagon","description":"Administered intravenously","armGroupLabels":["LY2189265 then Placebo","Placebo then LY2189265"],"otherNames":["Glucagon hydrochloride"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Maximum Insulin Concentration (Cmax) - First Phase Response","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax\\[0-10\\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.","timeFrame":"0-10 minutes after dextrose bolus on Day 3 postdose"},{"measure":"Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC\\[0-10\\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.","timeFrame":"0-10 minutes after dextrose bolus on Day 3 postdose"},{"measure":"Maximum Insulin Concentration (Cmax) - Second Phase Response","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax\\[10-180\\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.","timeFrame":"10-180 minutes after dextrose bolus on Day 3 postdose"},{"measure":"Insulin Area Under the Curve (AUC) - Second Phase Response","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC\\[10-180\\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.","timeFrame":"10-180 minutes after dextrose bolus on Day 3 post dose"}],"secondaryOutcomes":[{"measure":"Insulin Maximum Concentration (Cmax)","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.","timeFrame":"After glucagon bolus on Day 3 postdose"}],"otherOutcomes":[{"measure":"Area Under the Insulin Concentration-time Curve (AUC)","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. Area under the plasma insulin concentration-time curve from -2 to 20 minutes following the glucagon bolus (INSAUCG) is presented.","timeFrame":"After glucagon bolus on Day 3 postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nAll Participants\n\n* Women must be surgically sterile (hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal as defined by age \\>45 years without use of oral contraceptive agents for greater than 1 year and have either:\n\n  * spontaneous amenorrhea greater than 12 months, or\n  * spontaneous amenorrhea 6 to 12 months with documented follicle stimulating hormone (FSH) \\>25 milli international units/milliliter (mIU/mL) and serum estradiol \\<73 picomoles/liter (pmol/L) (20 picograms/milliliter \\[pg/mL\\])\n* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Have given written informed consent approved by Lilly and the ethical review board governing the site\n* Have serum creatinine \\<150 micromoles/liter (µmol/L) (\\<1.3 milligrams/deciliter \\[mg/dl\\] in women, \\<170 µmol/L \\[\\<1.5 mg/dL\\] in men)\n* Have normal hemoglobin result, as determined by the investigator\n\nHealthy Participants\n\n* Overtly healthy men and women as determined by medical history, normal lab results and physical examination.\n* Body mass index (BMI) between 19 and 25 kilograms/meter squared (kg/m\\^2), inclusive.\n* Normal blood pressure and heart rate as determined by the investigator\n* Have a normal response to an oral glucose tolerance test (OGTT) (glucose \\<7.8 millimoles/liter \\[mmol/L\\] \\[\\<140 mg/dL\\] at 2 hours after 75 grams (g) oral glucose load)\n\nParticipants with type 2 diabetes mellitus (T2DM)\n\n* Participants will have a BMI between 22.0 and 40.0 kg/m\\^2\n* Have T2DM controlled with diet and exercise alone or metformin for at least 4 weeks prior to admission\n* Have a hemoglobin A1c (HbA1c) value at screening (or within 4 weeks prior to screening) of 6.0% to 9.5%\n* Diagnosed with T2DM within the past 10 years\n* Clinical laboratory test results within normal range or deemed clinically insignificant by the Investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.\n* Participants who are taking stable-dose prescription medications (for example, antihypertensive agents, aspirin, lipid-lowering agents) for treatment of concurrent medical conditions are permitted to participate providing the medication is not associated with development of torsade de pointes. However, use of beta-blockers and thiazide diuretics are not permitted during this study.\n\nExclusion Criteria:\n\nAll Participants\n\n* Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication\n* Known allergies to Glucagon-Like Peptide 1 (GLP-1) related compounds\n* Have previously completed or withdrawn from this study or any other study in the last year investigating glucagon-like peptides or incretin mimetics including exenatide (Byetta®)\n* Regular use of known drugs of abuse and/or positive findings on urinary drug screening, other than findings consistent with medication prescribed by the participant's physician(s)\n* History or presence of cardiovascular, respiratory, renal, endocrine (except T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data\n* Have a history or presence of gastrointestinal disorder\n* Poorly controlled hypertension (systolic greater than 160 millimeters of mercury \\[mmHg\\], diastolic greater than 95 mmHg) and/or evidence of labile blood pressure including symptomatic postural hypotension. Use of beta-blockers or thiazide diuretics is not permitted during the study\n* Have a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year of the screening period\n* Evidence of hepatitis C and/or positive hepatitis C antibody\n* Evidence of hepatitis B and/or positive hepatitis B surface antigen\n* Evidence of human immunodeficiency virus (HIV) and/or positive for HIV antibodies\n* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to follow alcohol restrictions (1 unit = 12 ounces \\[oz\\] or 360 milliliters\\[mL\\] of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).\n* Smoke more than 10 cigarettes or equivalent in nicotine use or nicotine substitutes per day\n* Regular use of systemic corticosteroids by oral, intravenous, or intramuscular route, or potent, inhaled, or intranasal steroids known to have a high rate of systemic absorption\n* Have a history or presence of significant active neuropsychiatric disease\n* Blood donation of more than 500 mL in the last 3 months or any blood donation within the last month\n* Any other condition, which in the opinion of the investigator would preclude participation in the study\n* An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator increases the risk of participating in the study.\n* Any clinically significant abnormal hematology, clinical chemistry, or urinary result(s) as determined by the investigator\n* Evidence of significant active uncontrolled endocrine or autoimmune abnormalities (for example thyroid disease, or pernicious anemia) as judged by the screening physician\n\nHealthy Participants\n\n* Intended use of over-the-counter or prescription medication 7 and 14 days, respectively, prior to dosing.\n\nParticipants with T2DM\n\n* Clinically significant peripheral vascular occlusive disease (PVOD).\n* Known severe exudative diabetic retinopathy\n* Known significant autonomic neuropathy as evidenced by urinary retention, diabetic diarrhea, or gastroparesis\n* Have experienced a ketoacidotic episode (pH less than 7.3) requiring hospitalization in the last 6 months\n* Outpatient use of insulin for control of diabetes within the past 2 years\n* Use of antidiabetic agents other than metformin in the 4 weeks prior to study entry or use of thiazolidinediones within 12 weeks of study entry","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 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":"Neuss","zip":"D-41460","country":"Germany","geoPoint":{"lat":51.19807,"lon":6.68504}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"LY2189265 First, Then Placebo","description":"Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2.\n\nOn Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes \\[min\\]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hr glucose \\>10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr \\[mL/hr\\] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.\n\nThere was a washout period of ≥28 days between Periods 1 \\& 2."},{"id":"FG001","title":"Placebo First, Then LY2189265","description":"Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2.\n\nOn Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes \\[min\\]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hr glucose \\>10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr \\[mL/hr\\] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.\n\nThere was a washout period of ≥28 days between Periods 1 \\& 2."}],"periods":[{"title":"Period 1 of Study: First Intervention","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Washout Period of at Least 28 Days","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Period 2 of Study: Second Intervention","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"16"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Healthy participants or participants with type 2 diabetes mellitus (T2DM) who received at least one dose of study drug (LY2189265 or Placebo).","groups":[{"id":"BG000","title":"Healthy Participants","description":"Includes healthy participants randomized to receive 1.5 milligram (mg) LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence."},{"id":"BG001","title":"Participants With Type 2 Diabetes Mellitus (T2DM)","description":"Includes participants with T2DM randomized to receive 1.5 mg LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"32"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"51.9","spread":"5.0"},{"groupId":"BG001","value":"56.3","spread":"6.1"},{"groupId":"BG002","value":"54.9","spread":"6.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"10"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"22"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"32"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"32"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Germany","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"32"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Maximum Insulin Concentration (Cmax) - First Phase Response","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax\\[0-10\\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.","populationDescription":"All participants (healthy and with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(0-10) first response phase data.","paramType":"GEOMETRIC_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"picomole per liter (pmol/L)","timeFrame":"0-10 minutes after dextrose bolus on Day 3 postdose","groups":[{"id":"OG000","title":"Healthy Participants: Placebo","description":"Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG001","title":"Healthy Participants: LY2189265","description":"Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG002","title":"Participants With Type 2 Diabetes Mellitus (T2DM): Placebo","description":"T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG003","title":"Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265","description":"T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"233","lowerLimit":"154","upperLimit":"352"},{"groupId":"OG001","value":"689","lowerLimit":"455","upperLimit":"1041"},{"groupId":"OG002","value":"74.3","lowerLimit":"46.8","upperLimit":"118"},{"groupId":"OG003","value":"401","lowerLimit":"252","upperLimit":"637"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"2.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.41","ciUpperLimit":"3.64"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) means ratio","paramValue":"5.40","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.09","ciUpperLimit":"7.13"}]},{"type":"PRIMARY","title":"Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC\\[0-10\\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.","populationDescription":"All participants (healthy and with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(0-10) first phase response data.","paramType":"GEOMETRIC_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"picomole times hour per liter (pmol*h/L)","timeFrame":"0-10 minutes after dextrose bolus on Day 3 postdose","groups":[{"id":"OG000","title":"Healthy Participants: Placebo","description":"Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG001","title":"Healthy Participants: LY2189265","description":"Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG002","title":"Participants With Type 2 Diabetes Mellitus (T2DM): Placebo","description":"T2DM participants first received a single subcutaneous injection of Placebo on Day 1. 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On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.9","lowerLimit":"15.0","upperLimit":"34.9"},{"groupId":"OG001","value":"70.7","lowerLimit":"46.3","upperLimit":"108"},{"groupId":"OG002","value":"5.06","lowerLimit":"2.90","upperLimit":"8.83"},{"groupId":"OG003","value":"40.1","lowerLimit":"22.8","upperLimit":"70.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"3.09","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.66","ciUpperLimit":"3.59"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"7.92","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.82","ciUpperLimit":"13.0"}]},{"type":"PRIMARY","title":"Maximum Insulin Concentration (Cmax) - Second Phase Response","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax\\[10-180\\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.","populationDescription":"All participants (healthy and with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(10-180) second response phase data.","paramType":"GEOMETRIC_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"picomole per liter (pmol/L)]","timeFrame":"10-180 minutes after dextrose bolus on Day 3 postdose","groups":[{"id":"OG000","title":"Healthy Participants: Placebo","description":"Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG001","title":"Healthy Participants: LY2189265","description":"Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG002","title":"Participants With Type 2 Diabetes Mellitus (T2DM): Placebo","description":"T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG003","title":"Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265","description":"T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"89.2","lowerLimit":"64.7","upperLimit":"123"},{"groupId":"OG001","value":"370","lowerLimit":"269","upperLimit":"511"},{"groupId":"OG002","value":"95.9","lowerLimit":"66.3","upperLimit":"139"},{"groupId":"OG003","value":"363","lowerLimit":"250","upperLimit":"526"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"4.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.45","ciUpperLimit":"5.00"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"3.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.99","ciUpperLimit":"4.78"}]},{"type":"PRIMARY","title":"Insulin Area Under the Curve (AUC) - Second Phase Response","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC\\[10-180\\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.","populationDescription":"All participants (healthy and with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(10-180) second response phase data.","paramType":"GEOMETRIC_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"picomole times hour per liter (pmol*h/L)","timeFrame":"10-180 minutes after dextrose bolus on Day 3 post dose","groups":[{"id":"OG000","title":"Healthy Participants: Placebo","description":"Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG001","title":"Healthy Participants: LY2189265","description":"Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG002","title":"Participants With Type 2 Diabetes Mellitus (T2DM): Placebo","description":"T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."},{"id":"OG003","title":"Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265","description":"T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"68.8","lowerLimit":"41.7","upperLimit":"114"},{"groupId":"OG001","value":"141","lowerLimit":"85.3","upperLimit":"232"},{"groupId":"OG002","value":"147","lowerLimit":"103","upperLimit":"209"},{"groupId":"OG003","value":"357","lowerLimit":"250","upperLimit":"511"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.011","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"2.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.26","ciUpperLimit":"3.31"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"2.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.71","ciUpperLimit":"3.47"}]},{"type":"SECONDARY","title":"Insulin Maximum Concentration (Cmax)","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.","populationDescription":"All participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmaxG data.","paramType":"GEOMETRIC_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"picomole per liter (pmol/L)","timeFrame":"After glucagon bolus on Day 3 postdose","groups":[{"id":"OG000","title":"Healthy Participants: Placebo","description":"Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered."},{"id":"OG001","title":"Healthy Participants: LY2189265","description":"Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered."},{"id":"OG002","title":"Participants With Type 2 Diabetes Mellitus (T2DM): Placebo","description":"T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered."},{"id":"OG003","title":"Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265","description":"T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"996","lowerLimit":"716","upperLimit":"1386"},{"groupId":"OG001","value":"1215","lowerLimit":"874","upperLimit":"1690"},{"groupId":"OG002","value":"1088","lowerLimit":"827","upperLimit":"1431"},{"groupId":"OG003","value":"1514","lowerLimit":"1151","upperLimit":"1991"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.021","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"1.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.04","ciUpperLimit":"1.43"},{"groupIds":["OG002","OG003"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.","paramType":"Geometric least squares (LS) mean ratio","paramValue":"1.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.27","ciUpperLimit":"1.53"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Area Under the Insulin Concentration-time Curve (AUC)","description":"On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. 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Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered"},{"id":"OG001","title":"Healthy Participants: LY2189265","description":"Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered."},{"id":"OG002","title":"Participants With Type 2 Diabetes Mellitus (T2DM): Placebo","description":"T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered."},{"id":"OG003","title":"Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265","description":"T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"239","lowerLimit":"167","upperLimit":"340"},{"groupId":"OG001","value":"341","lowerLimit":"239","upperLimit":"486"},{"groupId":"OG002","value":"236","lowerLimit":"177","upperLimit":"316"},{"groupId":"OG003","value":"414","lowerLimit":"310","upperLimit":"554"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.009","pValueComment":"P-value is two-sided.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random 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