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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBDD | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
The term rescue therapy in this trial was defined as therapy for participants who met criteria for persistent severe hyperglycemia and therapy for participants who required new intervention for any other reason. The latter included participants who discontinued study drug due to adverse events, participant decision, or any other reason. For efficacy analyses, participants who received rescue medication were included in the analysis population, but only measurements obtained prior to taking rescue therapy were included in the efficacy analysis. For safety analyses, with the exception of hypoglycemia, all measurements including those obtained after taking rescue therapy were included in the analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.5 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
| 0.75 mg LY2189265 | Experimental | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
| Insulin Glargine | Active Comparator | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug |
| ||
| LY2189265 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) | Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c. | Baseline, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c) | Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c. | Baseline, 52 weeks |
| Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Concord | California | 94520 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29430801 | Derived | Pantalone KM, Patel H, Yu M, Fernandez Lando L. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018 Jun;20(6):1461-1469. doi: 10.1111/dom.13252. Epub 2018 Mar 23. | |
| 27161178 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.5 mg LY2189265 | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| FG001 | 0.75 mg LY2189265 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Insulin Lispro | Drug |
|
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model. |
| 26 weeks and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia | The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model. | Baseline, 26 weeks, and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles | The self-monitored plasma glucose (SMPG) data were 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 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose | Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine) | Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks. | Baseline and 26 weeks and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in Body Weight | Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Baseline and 52 weeks and 4 weeks after last dose |
| Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in the EQ-5D | The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline. | Baseline, 26 weeks, and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) | The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) | The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS) | The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes | Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured. | Baseline, 26 weeks, and 52 weeks |
| Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD). | Baseline and 52 weeks and 4 weeks after last dose |
| Change From Baseline to 26 and 52 Weeks in Serum Calcitonin | Baseline, 26 weeks, and 52 weeks |
| Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Baseline and 52 weeks and 4 weeks after last dose |
| Change From Baseline to 26 and 52 Weeks in Blood Pressure | Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. | Baseline and 52 weeks and 4 weeks after last dose |
| Change From Baseline to 26 and 52 Weeks in Pulse Rate | Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate | Baseline, 26 weeks, and 52 weeks |
| Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Seated pulse rate was measured. | Baseline and 52 weeks and 4 weeks after last dose |
| Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate | Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate. | Baseline, 26 weeks, and 52 weeks |
| Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose | The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 52 weeks |
| Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose | Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 26 weeks and 52 weeks |
| Rate of Self-reported Hypoglycemic Events up to 52 Weeks | Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 52 weeks |
| Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks | Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 52 weeks |
| Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose | A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. | Baseline through 4 weeks after last dose |
| Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose | A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose |
| United States |
| 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. | La Mesa | California | 91942 | United States |
| 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. | Lancaster | California | 93534 | United States |
| 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. | New Britain | Connecticut | 06050 | United States |
| 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. | Hollywood | Florida | 33021 | United States |
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| 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. | Genk | 3600 | Belgium |
| 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. | Liège | 4000 | Belgium |
| 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. | Belém | 66073-000 | Brazil |
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| 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. | London | Ontario | N6G 4X8 | Canada |
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| 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. | Budapest | 1115 | Hungary |
| 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. | Gyöngyös | 3200 | Hungary |
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| 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. | Pápa | 8500 | Hungary |
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| 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. | Yabucoa | 00767 | Puerto Rico |
| 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. | Moscow | 127486 | Russia |
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| Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7. |
| 26691396 | Derived | Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4. |
| 26009229 | Derived | Blonde L, Jendle J, Gross J, Woo V, Jiang H, Fahrbach JL, Milicevic Z. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015 May 23;385(9982):2057-66. doi: 10.1016/S0140-6736(15)60936-9. |
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| FG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who were randomized and received at least 1 dose of LY2189265 or Insulin Glargine.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1.5 mg LY2189265 | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| BG001 | 0.75 mg LY2189265 | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| BG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Weight | Mean | Standard Deviation | kilograms (kg) |
| |||||||||||||||
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
| ||||||||||||||
| Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
| |||||||||||||||
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) | Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. 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. | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline, 26 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c) | Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. 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. | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline, 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52 | The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. 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. | Number | percentage of participants | 26 weeks and 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia | The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used. 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. | Number | percentage of participants | Baseline, 26 weeks, and 52 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles | The self-monitored plasma glucose (SMPG) data were 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 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMPG data. Only pre-rescue measurements were used. | Least Squares Mean | Standard Error | millimoles per liter (mmol/L)] | Baseline, 26 weeks, and 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose | Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used. | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | Baseline, 26 weeks, and 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine) | Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. | Mean | Standard Deviation | units | Baseline and 26 weeks and 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 26 and 52 Weeks in Body Weight | Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight 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. | Least Squares Mean | Standard Error | kilograms (kg) | Baseline, 26 weeks, and 52 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. | Mean | Standard Deviation | kilograms (kg) | Baseline and 52 weeks and 4 weeks after last dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data. | Least Squares Mean | Standard Error | kilograms per meter squared (kg/m^2) | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Change From Baseline to 26 and 52 Weeks in the EQ-5D | The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. 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. | Least Squares Mean | Standard Error | units on a scale | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) | The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. 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. | Least Squares Mean | Standard Error | units on a scale | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) | The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. 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. | Least Squares Mean | Standard Error | units on a scale | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS) | The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. 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. | Least Squares Mean | Standard Error | units on a scale | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes | Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme 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. | Median | Inter-Quartile Range | units per liter (U/L) | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD). | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. | Mean | Standard Deviation | units per liter (U/L) | Baseline and 52 weeks and 4 weeks after last dose |
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| Secondary | Change From Baseline to 26 and 52 Weeks in Serum Calcitonin | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin 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 | Median | Inter-Quartile Range | picogram per milliliter (pcg/mL) | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. | Mean | Standard Deviation | picomole per liter | Baseline and 52 weeks and 4 weeks after last dose |
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| Secondary | Change From Baseline to 26 and 52 Weeks in Blood Pressure | Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data. | Least Squares Mean | Standard Error | milliliters of mercury (mmHg) | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data. | Mean | Standard Deviation | milliliters of mercury (mmHg) | Baseline and 52 weeks and 4 weeks after last dose |
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| Secondary | Change From Baseline to 26 and 52 Weeks in Pulse Rate | Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data. | Least Squares Mean | Standard Error | beats per minute (bpm) | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose | Seated pulse rate was measured. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data. | Mean | Standard Deviation | beats per minute (bpm) | Baseline and 52 weeks and 4 weeks after last dose |
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| Secondary | Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data. | Least Squares Mean | Standard Error | milliseconds (msec) | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate | Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data. | Least Squares Mean | Standard Error | beats per minute (bpm) | Baseline, 26 weeks, and 52 weeks |
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| Secondary | Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose | The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. | Number | events | Baseline through 52 weeks |
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| Secondary | Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose | Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used. | Number | participants | Baseline through 26 weeks and 52 weeks |
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| Secondary | Rate of Self-reported Hypoglycemic Events up to 52 Weeks | Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used. | Mean | Standard Deviation | events per participant per year | Baseline through 52 weeks |
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| Secondary | Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks | Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. | Number | participants | Baseline through 52 weeks |
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| Secondary | Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose | A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. | Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data. | Number | participants | Baseline through 4 weeks after last dose |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose | A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. | Number | participants | Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1.5 mg LY2189265 | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks | 27 | 295 | 219 | 295 | ||
| EG001 | 0.75 mg LY2189265 | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks | 46 | 293 | 232 | 293 | ||
| EG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks | 53 | 296 | 203 | 296 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Hemorrhagic anemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Atrioventricular block third degree | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Cardiac pain | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA 15.0 | Systematic Assessment | Event resulted in death |
|
| Chest pain - cardiac | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Congestive heart failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Coronary artery insufficiency | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Coronary atherosclerosis | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Coronary insufficiency | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Decompensated heart failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Fibrillation ventricular | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Heart block third degree | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Infarct myocardial | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Non st segment elevation myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Non stemi | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Non-sustained ventricular tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Unstable angina | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment | Event resulted in death |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Retinal hemorrhage | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal herniation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Chronic diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Colonic polyp | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gastroenteritis noninfectious | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Hemorrhoidal bleeding | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Paralytic ileus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Chest pain exertional | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Generalised oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Generalized edema | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Multiple organ failure | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Acute cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Ancylostomiasis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Cellulitis of foot | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Cellulitis of leg | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Epiglottitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Gangrenous appendicitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Gastroenteritis norovirus | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Hookworm infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Infected bites | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Infected toe | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Pleurisy viral | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment | One event resulted in one death in 0.75 mg LY2189265 arm |
|
| Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment | One event resulted in one death in 1.5 mg LY2189265 arm |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Staphylococcus aureus septicemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Supraglottitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Urinary infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Falling | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Fractured ribs | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Fractured sternum | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Knee fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Leg injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Lumbar vertebral fracture l1 | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Meniscus tear | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Quadriceps tendon rupture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Suture related complication | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Torn muscle | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoglycemic episode | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cervical pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lumbar pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Osteoarthritis aggravated | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rotator cuff tear | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Gallbladder adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hemorrhagic stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoglycemic coma | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ischemic stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lumboischialgia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Orthostatic collapse | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Palsy bells | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Transient cerebral ischemia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Unilateral carpal tunnel syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Viith nerve paralysis | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mental confusion | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Psychosis | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal stone | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Unilateral renal artery stenosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ureteral calculus | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ureteric calculus | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Premenopausal menorrhagia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atherosclerosis generalized | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bleeding | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Common cold | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Flu syndrome | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyslipidemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C555680 | dulaglutide |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Taiwan |
|
| Greece |
|
| Spain |
|
| Russian Federation |
|
| Hungary |
|
| Mexico |
|
| Canada |
|
| Puerto Rico |
|
| Argentina |
|
| Poland |
|
| Brazil |
|
| Belgium |
|
| Denmark |
|
| Australia |
|
| Sweden |
|
If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine. |
| ANCOVA | <0.001 | Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy. | LS Mean Difference | -0.17 | 2-Sided | 95 | -0.33 | -0.02 | Yes | Non-Inferiority or Equivalence | If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine. |
| Superiority analysis. | ANCOVA | 0.005 | Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy. | LS Mean Difference | -0.22 | 2-Sided | 95 | -0.38 | -0.07 | No | Superiority or Other |
| Superiority analysis. | ANCOVA | 0.015 | Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy. | LS Mean Difference | -0.17 | 2-Sided | 95 | -0.33 | -0.02 | No | Superiority or Other |
Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
|
|
|
| Insulin Glargine |
Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
|
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
|
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
|
Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| OG001 | 0.75 mg LY2189265 | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
| OG001 |
| 0.75 mg LY2189265 |
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
| OG001 | 0.75 mg LY2189265 | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
|
|
|
|
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
| OG002 | Insulin Glargine | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
| OG002 |
| Insulin Glargine |
Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
|
|
|
Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
|
|