What AWARD-6 measured first
| 1.5 mg LY2189265n=279 | 1.8 mg Liraglutiden=272 |
|---|---|
| -1.42(0.05) | -1.36(0.05) |
A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)
Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (percentage of glycosylated hemoglobin), Baseline, 26 Weeks. 1.5 mg LY2189265: -1.42; 1.8 mg Liraglutide: -1.36.
As posted on ClinicalTrials.gov (NCT01624259), updated at source Oct 9, 2014. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| 1.5 mg LY2189265n=279 | 1.8 mg Liraglutiden=272 |
|---|---|
| -1.42(0.05) | -1.36(0.05) |
Percent of participants affected. The most common events the registry lists.
| Event | 1.5 mg LY2189265 | 1.8 mg Liraglutide |
|---|---|---|
| Any serious event | 1.7% | 3.7% |
| Nausea | 20.4% | 18% |
| Diarrhoea | 12% | 12% |
| Vomiting | 7% | 8.3% |
| Headache | 7.4% | 8.3% |
| Dyspepsia | 8% | 6% |
| Nasopharyngitis | 7.7% | 7% |
| Decreased appetite | 5.4% | 6.7% |
| Constipation | 3.7% | 5.7% |
| Back pain | 3.7% | 5% |
| 1.5 mg LY2189265n=299 | 1.8 mg Liraglutiden=299 |
|---|---|
| -2.90(0.22) | -3.61(0.22) |
| 1.5 mg LY2189265n=299 | 1.8 mg Liraglutiden=299 |
|---|---|
| -1.05(0.08) | -1.30(0.08) |
| 1.5 mg LY2189265n=281 | 1.8 mg Liraglutiden=277 |
|---|---|
| -34.81(2.13) | -34.25(2.11) |
| 1.5 mg LY2189265n=248 | 1.8 mg Liraglutiden=256 |
|---|---|
| -40.76(1.50) | -38.51(1.45) |
| Measure | 1.5 mg LY2189265n=293 | 1.8 mg Liraglutiden=293 |
|---|---|---|
| HbA1c levels ≤6.5% | 54.6 | 50.9 |
| HbA1c levels <7.0% | 68.3 | 67.9 |
| 1.5 mg LY2189265n=275 | 1.8 mg Liraglutiden=265 |
|---|---|
| 37.03(2.26) | 35.59(2.27) |
| Measure | 1.5 mg LY2189265n=299 | 1.8 mg Liraglutiden=300 |
|---|---|---|
| Any reported CV events | 0 | 3 |
| Any adjudicated nonfatal CV events | 0 | 1 |
| Any confirmed adjudicated deaths | 0 | 0 |
| 1.5 mg LY2189265n=273 | 1.8 mg Liraglutiden=284 |
|---|---|
| 1.9(0.55) | 4.1(0.54) |
| Measure | 1.5 mg LY2189265n=273 | 1.8 mg Liraglutiden=284 |
|---|---|---|
| PR interval (n=270, 278) | 3.8(0.81) | 3.3(0.80) |
| QTcF interval (n=273, 284) | 0.39(0.90) | -0.72(0.89) |
| 1.5 mg LY2189265n=288 | 1.8 mg Liraglutiden=288 |
|---|---|
| 2.37(0.4) | 3.12(0.4) |
| Measure | 1.5 mg LY2189265n=278 | 1.8 mg Liraglutiden=281 |
|---|---|---|
| Sitting DBP | -0.22(0.4) | -0.31(0.4) |
| Sitting SBP | -3.36(0.7) | -2.82(0.7) |
| 1.5 mg LY2189265n=299 | 1.8 mg Liraglutiden=300 |
|---|---|
| 0 | 0 |
The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.
Inclusion Criteria: * Type 2 diabetes * Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit * Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0% * Accept continued treatment with metformin throughout the trial, as required per protocol * Men and nonpregnant women aged greater than or equal to 18 years * Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening * Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m\^2) Exclusion Criteria: * Have type 1 diabetes mellitus * Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 3 months prior to the first study visit * Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit * Have been treated with drugs that promote weight loss within 3 months of the first study visit * Are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit * Have had any of the following cardiovascular conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident * Have a known clinically significant gastric emptying abnormality (such as, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery * Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level greater than or equal to 3 times the upper limit of normal * Have a history of chronic pancreatitis or acute idiopathic pancreatitis or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit * Have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute) * Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B, respectively) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation) * Have any self or family history of medullary C-cell...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.