Phase 3 · Dulaglutide

NCT01126580 trial results

The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (percentage of glycosylated hemoglobin), Baseline, 26 weeks. 1.5 mg LY2189265: -0.78; 0.75 mg LY2189265: -0.71; Metformin: -0.56.

Participants
807
Status
completed
Completed
2012-06
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01126580), updated at source Jan 16, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01126580 measured first

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)percentage of glycosylated hemoglobin · Baseline, 26 weeks · least squares mean
1.5 mg LY2189265n=2650.75 mg LY2189265n=265Metforminn=265
-0.78(0.06)-0.71(0.06)-0.56(0.06)
Side effects by arm

Side effects in NCT01126580

Percent of participants affected. The most common events the registry lists.

Event1.5 mg LY21892650.75 mg LY2189265Metformin
Any serious event5.6%7.4%6%
Nausea19.7%11.5%16%
Diarrhoea11.5%9.6%14.6%
Nasopharyngitis5.2%3.3%10.4%
Vomiting9.7%7.4%5.2%
Headache3.7%5.2%7.5%
Constipation6.7%4.4%1.1%
Decreased appetite6.7%4.4%4.5%
Upper respiratory tract infection5.9%6.3%3%
Abdominal distension4.8%4.8%3.7%
Dyspepsia4.5%3%2.2%
Back pain1.9%3.3%4.5%
Dizziness1.9%4.4%3.4%
Abdominal pain4.1%3.7%2.2%
Bronchitis2.6%4.1%3.4%
Influenza3.3%4.1%3%
Urinary tract infection3.7%4.1%2.2%
Secondary outcomes

What else it measured

Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)percentage of glycosylated hemoglobin · Baseline, 52 weeks · least squares mean
1.5 mg LY2189265n=2650.75 mg LY2189265n=265Metforminn=265
-0.70(0.07)-0.55(0.07)-0.51(0.07)
Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weekspercentage of participants · 26 weeks and 52 weeks · number
Measure1.5 mg LY2189265n=2650.75 mg LY2189265n=265Metforminn=265
HbA1c less than 7%, 26 weeks61.562.653.6
HbA1c less than or equal to 6.5%, 26 weeks46.040.029.8
HbA1c less than 7%, 52 weeks60.053.248.3
HbA1c less than or equal to 6.5%, 52 weeks42.334.728.3
Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucosemillimoles per liter (mmol/L) · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2670.75 mg LY2189265n=265Metforminn=264
26 weeks (n=244, 247, 245)-1.61(0.13)-1.46(0.13)-1.34(0.13)
52 weeks (n=207, 210, 194)-1.56(0.14)-1.00(0.14)-1.15(0.14)
Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profilesmillimoles per liter (mmol/L) · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2110.75 mg LY2189265n=207Metforminn=218
26 weeks (n=195, 200, 211)-1.98(0.15)-1.75(0.14)-1.68(0.14)
52 weeks (n=197, 200, 212)-1.99(0.16)-1.71(0.16)-1.58(0.15)
Change From Baseline to 26 and 52 Weeks in Body Weightkilograms (kg) · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2690.75 mg LY2189265n=270Metforminn=268
26 weeks (n=267, 269, 267)-2.29(0.24)-1.36(0.24)-2.22(0.24)
52 weeks (n=267, 269, 267)-1.93(0.29)-1.09(0.29)-2.20(0.29)
Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)kilograms per meter squared (kg/m^2) · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2670.75 mg LY2189265n=269Metforminn=267
26 weeks-0.86(0.09)-0.51(0.09)-0.82(0.09)
52 weeks-0.73(0.11)-0.42(0.10)-0.83(0.11)
Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Functionpercentage of HOMA2 · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2450.75 mg LY2189265n=242Metforminn=242
HOMA2-%B, 26 weeks (n=207, 207, 215)36.55(3.42)28.96(3.44)14.11(3.37)
HOMA2-%B, 52 weeks (n=179, 185, 170)29.97(3.46)22.5(3.46)9.77(3.51)
HOMA2-%S, 26 weeks (n=207, 207, 215)0.95(2.29)2.71(2.29)9.99(2.25)
HOMA2-%S, 52 weeks (n=179, 185, 170)5.29(2.43)1.84(2.43)10.83(2.48)
Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Scoreunits on a scale · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2660.75 mg LY2189265n=268Metforminn=266
26 weeks (n=247, 251, 247)0.09(0.33)0.19(0.32)0.02(0.32)
52 weeks (n=247, 252, 248)0.39(0.33)-0.05(0.33)0.28(0.33)
Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Scoreunits on a scale · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2680.75 mg LY2189265n=270Metforminn=268
26 weeks (n=248, 254, 249)0.72(0.19)0.63(0.18)0.79(0.18)
52 weeks (n=249, 255, 250)0.45(0.19)0.61(0.19)0.75(0.19)
Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Versionunits on a scale · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2660.75 mg LY2189265n=267Metforminn=267
26 weeks (n=244, 249, 241)1.93(0.39)1.81(0.38)2.04(0.39)
52 weeks (n=245, 251, 244)1.82(0.44)1.29(0.43)1.94(0.44)
Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Versionunits on a scale · 52 weeks · least squares mean
1.5 mg LY2189265n=2300.75 mg LY2189265n=235Metforminn=230
12.92(0.52)12.73(0.50)12.58(0.51)
Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Scoreunits on a scale · Baseline, 26 weeks, and 52 weeks · least squares mean
Measure1.5 mg LY2189265n=2670.75 mg LY2189265n=270Metforminn=267
26 weeks (n=245, 253, 248)0.24(0.36)-0.16(0.35)0.41(0.35)
52 weeks (n=247, 255, 249)0.49(0.39)0.42(0.39)0.59(0.39)
The trial

How NCT01126580 was run

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.

  • 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
  • 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
  • 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
Who could join the trial

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...

Published papers

Papers from NCT01126580

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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