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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

NCTNCT01126580 (opens ClinicalTrials.gov in a new tab)Other id11375Other idH9X-MC-GBDCOther idCTRI/2010/091/003036
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
807 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Quadruple masking
Countries
19 countries

United States, Argentina, Brazil, Canada, Croatia, Czechia, Finland, France, Germany, India, Mexico, Poland, Puerto Rico, Romania, Slovakia, South Africa, South Korea, Spain, United Kingdom

Start
May 2010
Primary completion
Nov 2011
Completion
Jun 2012
First posted
19 May 2010 (estimated)
Last update posted
16 Jan 2015 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 3

    A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

    NCT01126580

    May 2010 to Jun 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.

Interventions

  • MetforminDrug
  • LY2189265Drug
  • Placebo (oral)Drug
  • Placebo (subcutaneous)Drug

Arms3

  • Experimental

    1.5 mg LY2189265

    LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks Placebo: 1 tablet per day, orally, for Week 1; 2 tablets per day, orally, for Week 2; 3 tablets per day, orally, for Week 3; 4 or at least 3 tablets, orally, for Weeks 4 through Week 52

  • Experimental

    0.75 mg LY2189265

    LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks Placebo: 1 tablet per day, orally, for Week 1; 2 tablets per day, orally, for Week 2; 3 tablets per day, orally, for Week 3; 4 or at least 3 tablets, orally, for Weeks 4 through Week 52

  • Active comparator

    Metformin

    Metformin: 500 milligrams per day (mg/day), orally, for Week 1; 1000 mg/day, orally, for Week 2; 1500 mg/day, orally, for Week 3; 2000 or at least 1500 mg/day, orally, for Weeks 4 through Week 52 Placebo: subcutaneously (SC), once weekly for 52 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

    Time frame · Baseline, 26 weeks

    Registry description

    Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication \[OAM\] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.

Secondary outcomes(20)

  1. Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)

    Time frame · Baseline, 52 weeks

    Registry description

    Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication \[OAM\] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.

  2. Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks

    Time frame · 26 weeks and 52 weeks

    Registry description

    The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model.

  3. Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.

  4. Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    The SMBG 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; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate.

  5. Change From Baseline to 26 and 52 Weeks in Body Weight

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate.

  6. Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate.

  7. Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect.

  8. Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living \[APPADL\]) questionnaire 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) adjusted by treatment, country, prior medication group, gender, and baseline score.

  9. Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    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) adjusted by treatment, country, prior medication group, gender, and baseline score.

  10. Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.

  11. Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version

    Time frame · 52 weeks

    Registry description

    The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.

  12. Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.

  13. Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks

    Time frame · 26 weeks and 52 weeks

    Registry description

    A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  14. Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.

  15. Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    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, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate.

  16. Change From Baseline to 26 and 52 Weeks in Pulse Rate

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    Sitting 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, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.

  17. Change From Baseline to 26 and 52 Weeks in Blood Pressure

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    Sitting systolic blood pressure (SBP) and sitting 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, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.

  18. Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.

  19. Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.

  20. Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame · Baseline, 26 weeks, and 52 weeks

    Registry description

    Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, 26 weeks

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

GroupValue (percentage of glycosylated hemoglobin)Spread
1.5 mg LY2189265-0.780.06
0.75 mg LY2189265-0.710.06
Metformin-0.560.06
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, 52 weeks

Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)

GroupValue (percentage of glycosylated hemoglobin)Spread
1.5 mg LY2189265-0.700.07
0.75 mg LY2189265-0.550.07
Metformin-0.510.07
Secondary outcomeNumber· 26 weeks and 52 weeks

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks

GroupValue (percentage of participants)
1.5 mg LY218926561.5
0.75 mg LY218926562.6
Metformin53.6
Secondary outcomeLeast squares mean· Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose

GroupValue (millimoles per liter (mmol/L))Spread
1.5 mg LY2189265-1.610.13
0.75 mg LY2189265-1.460.13
Metformin-1.340.13
Secondary outcomeLeast squares mean· Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

GroupValue (millimoles per liter (mmol/L))Spread
1.5 mg LY2189265-1.980.15
0.75 mg LY2189265-1.750.14
Metformin-1.680.14
Secondary outcomeLeast squares mean· Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Body Weight

GroupValue (kilograms (kg))Spread
1.5 mg LY2189265-2.290.24
0.75 mg LY2189265-1.360.24
Metformin-2.220.24
Secondary outcomeLeast squares mean· Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)

GroupValue (kilograms per meter squared (kg/m^2))Spread
1.5 mg LY2189265-0.860.09
0.75 mg LY2189265-0.510.09
Metformin-0.820.09
Secondary outcomeLeast squares mean· Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function

GroupValue (percentage of HOMA2)Spread
1.5 mg LY218926536.553.42
0.75 mg LY218926528.963.44
Metformin14.113.37

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1.5 mg LY2189265LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks Placebo: orally, twice daily for 52 weeks–15 / 269177 / 269
0.75 mg LY2189265LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks Placebo: orally, twice daily for 52 weeks–20 / 270178 / 270
MetforminMetformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks Placebo: subcutaneously (SC), once weekly for 52 weeks–16 / 268170 / 268

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2016

6 results

Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme.

Yu et al. 2016Diabetes, obesity & metabolismcited by 26

PMID 26691396DOI 10.1111/dom.12624PUB-26691396

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2014

10 results

Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).

Umpierrez et al. 2014Diabetes carecited by 272

PMID 24842985DOI 10.2337/dc13-2759PUB-24842985

Full text at the publisher10 results
Publisher pageSee results (10)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2. PMID 32501595
  • DerivedBoustani 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. PMID 27161178

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organization's \[WHO\] Classification of Diabetes). * Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label. * Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin. * Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%. * Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: a) test negative for pregnancy at screening based on a serum pregnancy test, and b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or c) not be breastfeeding. * Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening. * Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2), inclusive. * Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary. Exclusion Criteria: * Have type 1 diabetes mellitus. * Are being or have been treated with any of the following medications: a) chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable, b) glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3 months prior to screening, e) chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or f) illegal drugs. * Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening. * Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery. * Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke. * Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women. * Have a problem with the liver or pancreas. * Have a creatinine clearance result which shows less than 60 milliliters per minute (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or active autoimmune abnormality. * Have a serum calcitonin test which shows greater than or equal to 20 picograms per milliliter (pcg/mL) at the time of screening. * Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B. * Have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years. * Have had an organ transplant except for corneal transplant. * Have received treatment within the last 30 days with a drug which has not been regulatory approved. * Have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 30 days prior to screening. * Have any condition that is a contraindication to or would interfere with medications provided for this study to treat diabetes. * Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab samples. * Have previously participated or signed an informed consent document for this same type of study and study drug.

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