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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01191268
Registration number
NCT01191268
Ethics application status
Date submitted
27/08/2010
Date registered
30/08/2010
Date last updated
8/10/2014
Titles & IDs
Public title
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
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Scientific title
The Impact of LY2189265 Versus Insulin Glargine in Combination With Insulin Lispro for the Treatment to Target of Type 2 Diabetes Mellitus (AWARD-4: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 4)
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Secondary ID [1]
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H9X-MC-GBDD
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Secondary ID [2]
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11376
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Insulin Glargine
Treatment: Drugs - LY2189265
Treatment: Drugs - Insulin Lispro
Experimental: 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
Experimental: 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
Active Comparator: 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
Treatment: Drugs: Insulin Glargine
Treatment: Drugs: LY2189265
Treatment: Drugs: Insulin Lispro
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)
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Assessment method [1]
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Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.
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Timepoint [1]
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Baseline, 26 weeks
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Secondary outcome [1]
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Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)
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Assessment method [1]
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Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.
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Timepoint [1]
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Baseline, 52 weeks
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Secondary outcome [2]
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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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Assessment method [2]
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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.
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Timepoint [2]
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26 weeks and 52 weeks
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Secondary outcome [3]
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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
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [4]
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Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [5]
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Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [6]
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Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and 26 weeks and 52 weeks
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Secondary outcome [7]
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Change From Baseline to 26 and 52 Weeks in Body Weight
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [8]
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Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [8]
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Timepoint [8]
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Baseline and 52 weeks and 4 weeks after last dose
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Secondary outcome [9]
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Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [10]
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Change From Baseline to 26 and 52 Weeks in the EQ-5D
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [11]
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Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [12]
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Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [13]
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Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [14]
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Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes
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Assessment method [14]
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Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.
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Timepoint [14]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [15]
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Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [15]
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Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).
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Timepoint [15]
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Baseline and 52 weeks and 4 weeks after last dose
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Secondary outcome [16]
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Change From Baseline to 26 and 52 Weeks in Serum Calcitonin
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Assessment method [16]
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Timepoint [16]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [17]
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Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [17]
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Timepoint [17]
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Baseline and 52 weeks and 4 weeks after last dose
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Secondary outcome [18]
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Change From Baseline to 26 and 52 Weeks in Blood Pressure
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [19]
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Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [19]
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Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.
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Timepoint [19]
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Baseline and 52 weeks and 4 weeks after last dose
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Secondary outcome [20]
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Change From Baseline to 26 and 52 Weeks in Pulse Rate
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Assessment method [20]
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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
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Timepoint [20]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [21]
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Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [21]
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Seated pulse rate was measured.
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Timepoint [21]
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Baseline and 52 weeks and 4 weeks after last dose
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Secondary outcome [22]
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Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
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Assessment method [22]
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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.
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Timepoint [22]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [23]
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Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate
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Assessment method [23]
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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.
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Timepoint [23]
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Baseline, 26 weeks, and 52 weeks
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Secondary outcome [24]
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Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [24]
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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.
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Timepoint [24]
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Baseline through 52 weeks
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Secondary outcome [25]
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Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [25]
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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.
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Timepoint [25]
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Baseline through 26 weeks and 52 weeks
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Secondary outcome [26]
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Rate of Self-reported Hypoglycemic Events up to 52 Weeks
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Assessment method [26]
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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.
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Timepoint [26]
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Baseline through 52 weeks
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Secondary outcome [27]
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Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks
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Assessment method [27]
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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.
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Timepoint [27]
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Baseline through 52 weeks
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Secondary outcome [28]
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Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [28]
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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.
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Timepoint [28]
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Baseline through 4 weeks after last dose
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Secondary outcome [29]
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Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose
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Assessment method [29]
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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.
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Timepoint [29]
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Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose
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Eligibility
Key inclusion criteria
- Type 2 diabetes
- Currently using insulin for at least 3 months with a conventional insulin regimen with
or without oral medications
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to
11%
- Willing to inject subcutaneous medication
- Willing to monitor blood glucose levels and adjust insulin dose
- Willing to maintain a study diary
- Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
- Stable weight for 3 months prior to screening
- Females of child bearing potential must test negative for pregnancy at screening and
be willing to use a reliable method of birth control during the study and for 1 month
following the last dose of study drug
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Type 1 Diabetes
- Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior
to screening
- 1 or more episodes of ketoacidosis within 6 months prior to screening
- Have been treated with prescription or over the counter medication to promote weight
loss within 3 months prior to screening
- Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per
minute per 1.73 square meters (mL/min/1.73 m^2) at screening
- Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
- History of heart failure, New York Heart Classification III or IV within 2 months
prior to screening
- Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery
(stomach stapling) or chronically taking medications that directly affect GI motility
- Acute or chronic hepatitis or pancreatitis
- Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary
C-Cell hyperplasia
- Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at
screening
- Organ transplant except cornea
- Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
- History of or active malignancy except skin or in situ cervical or prostate cancer
within the last 5 years
- Known drug or alcohol abuse
- Have enrolled in another clinical trial within the last 30 days
- Have previously signed an informed consent or participated in a LY2189265 study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2012
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Sample size
Target
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Accrual to date
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Final
884
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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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. - Keswick
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Recruitment hospital [2]
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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. - Box Hill
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Recruitment hospital [3]
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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. - Melbourne
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Recruitment postcode(s) [1]
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5035 - Keswick
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
California
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Country [2]
0
0
United States of America
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State/province [2]
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0
Connecticut
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Country [3]
0
0
United States of America
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State/province [3]
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0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Hawaii
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Country [5]
0
0
United States of America
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State/province [5]
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0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kansas
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Country [7]
0
0
United States of America
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State/province [7]
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0
Kentucky
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Country [8]
0
0
United States of America
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State/province [8]
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0
Louisiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Minnesota
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Missouri
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Country [12]
0
0
United States of America
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State/province [12]
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0
New Hampshire
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New Jersey
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Country [14]
0
0
United States of America
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State/province [14]
0
0
New York
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Country [15]
0
0
United States of America
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State/province [15]
0
0
North Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
North Dakota
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Oregon
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Country [18]
0
0
United States of America
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State/province [18]
0
0
South Carolina
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Tennessee
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Country [20]
0
0
United States of America
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State/province [20]
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0
Texas
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Country [21]
0
0
United States of America
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State/province [21]
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0
Washington
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Country [22]
0
0
Argentina
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State/province [22]
0
0
Buenos Aires
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Taiwan
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Yong Kang City
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Funding & Sponsors
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Name
Eli Lilly and Company
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01191268
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Contacts
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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)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01191268
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