Primary outcome
What AWARD-1 measured first
| 1.5 mg LY2189265n=271 | 0.75 mg LY2189265n=269 | Exenatiden=266 | Placebon=119 |
|---|---|---|---|
| -1.51(0.06) | -1.30(0.06) | -0.99(0.06) | -0.46(0.08) |
Phase 3 · Dulaglutide
AWARD-1 trial results
A Randomized, Placebo-Controlled Comparison of the Effects of Two Doses of LY2189265 or Exenatide on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Pioglitazone (AWARD-1: Assessment of Weekly Administration of LY2189265 in Diabetes-1)
Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (percentage of glycosylated hemoglobin), Baseline, 26 weeks. 1.5 mg LY2189265: -1.51; 0.75 mg LY2189265: -1.30; Exenatide: -0.99; Placebo: -0.46.
- Participants
- 978
- Status
- completed
- Completed
- 2012-05
- Sponsor
- Eli Lilly and Company
As posted on ClinicalTrials.gov (NCT01064687), updated at source Jan 26, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in AWARD-1
Percent of participants affected. The most common events the registry lists.
| Event | 0.75 mg LY2189265 (Baseline Through 26 Weeks) | 1.5 mg LY2189265 (Baseline Through 26 Weeks) | Exenatide (Baseline Through 26 Weeks) | Placebo (Baseline Through 26 Weeks) | 0.75 mg LY2189265 (Baseline Through 56 Weeks) | 1.5 mg LY2189265 (Baseline Through 56 Weeks) | Exenatide (Baseline Through 56 Weeks) | Placebo/0.75 mg LY2189265 (26 Weeks Through 56 Weeks) | Placebo/1.5 mg LY2189265 (26 Weeks Through 56 Weeks) |
|---|---|---|---|---|---|---|---|---|---|
| Any serious event | 5.4% | 4.3% | 5.4% | 8.5% | 7.9% | 6.5% | 9.7% | 9.7% | 14.5% |
| Nausea | 16.1% | 28% | 25.5% | 5.7% | 16.8% | 29.4% | 27.7% | 9.7% | 24.2% |
| Vomiting | 6.1% | 16.8% | 10.8% | 1.4% | 6.1% | 17.2% | 12.2% | 4.8% | 8.1% |
| Oedema peripheral | 4.6% | 1.1% | 4% | 5% | 5.4% | 2.9% | 6.1% | 14.5% | 4.8% |
| Diarrhoea | 7.9% | 11.1% | 5.8% | 5.7% | 9.3% | 13.3% | 7.9% | 8.1% | 12.9% |
| Nasopharyngitis | 8.2% | 6.5% | 4.3% | 5.7% | 9.3% | 10% | 5.8% | 8.1% | 3.2% |
| Dyspepsia | 1.8% | 7.9% | 6.8% | 2.8% | 2.1% | 8.2% | 7.6% | 0% | 9.7% |
| Headache | 3.2% | 7.2% | 8.6% | 5.7% | 5% | 9.3% | 9% | 8.1% | 9.7% |
| Upper respiratory tract infection | 5% | 4.3% | 4.3% | 4.3% | 8.9% | 5.7% | 7.2% | 8.1% | 6.5% |
| Decreased appetite | 5% | 7.9% | 2.9% | 2.1% | 5.4% | 8.2% | 3.2% | 3.2% | 4.8% |
| Urinary tract infection | 2.9% | 3.9% | 2.2% | 2.8% | 4.6% | 5.7% | 5% | 3.2% | 8.1% |
| Back pain | 3.2% | 3.9% | 2.9% | 6.4% | 5% | 5.4% | 4.3% | 6.5% | 8.1% |
| Oropharyngeal pain | 1.4% | 1.8% | 1.1% | 5% | 2.5% | 2.5% | 1.1% | 6.5% | 8.1% |
| Hypertension | 2.1% | 2.5% | 1.1% | 4.3% | 2.5% | 2.9% | 2.2% | 1.6% | 8.1% |
| Fatigue | 4.3% | 3.6% | 7.6% | 1.4% | 4.6% | 4.7% | 7.9% | 4.8% | 3.2% |
| Dizziness | 2.9% | 5.4% | 6.5% | 1.4% | 3.6% | 6.8% | 7.6% | 0% | 3.2% |
| Constipation | 1.8% | 4.3% | 1.8% | 1.4% | 1.8% | 5.7% | 1.8% | 3.2% | 6.5% |
| Influenza | 2.9% | 1.8% | 2.5% | 2.8% | 4.3% | 4.3% | 5% | 6.5% | 4.8% |
| Lipase increased | 1.1% | 2.5% | 1.8% | 2.8% | 2.1% | 3.2% | 3.2% | 6.5% | 3.2% |
| Pain in extremity | 2.9% | 2.2% | 2.9% | 4.3% | 4.6% | 4.3% | 5.4% | 4.8% | 6.5% |
| Arthralgia | 3.6% | 2.9% | 3.2% | 2.1% | 6.1% | 4.3% | 4.7% | 4.8% | 3.2% |
| Sinusitis | 2.1% | 1.8% | 3.6% | 1.4% | 3.2% | 4.3% | 5.8% | 3.2% | 0% |
| Flatulence | 1.1% | 5% | 2.2% | 2.1% | 1.1% | 5.7% | 2.5% | 0% | 4.8% |
Secondary outcomes
What else it measured
| 1.5 mg LY2189265n=271 | 0.75 mg LY2189265n=269 | Exenatiden=266 |
|---|---|---|
| -1.36(0.08) | -1.07(0.08) | -0.80(0.08) |
| 1.5 mg LY2189265n=259 | 0.75 mg LY2189265n=253 | Exenatiden=245 | Placebon=109 |
|---|---|---|---|
| -1.34(0.25) | 0.18(0.25) | -1.14(0.26) | 1.37(0.37) |
| 1.5 mg LY2189265n=238 | 0.75 mg LY2189265n=231 | Exenatiden=210 |
|---|---|---|
| -1.08(0.34) | 0.49(0.34) | -0.76(0.35) |
| 1.5 mg LY2189265n=259 | 0.75 mg LY2189265n=253 | Exenatiden=245 | Placebon=109 |
|---|---|---|---|
| -0.48(0.09) | 0.07(0.09) | -0.41(0.09) | 0.49(0.13) |
| 1.5 mg LY2189265n=238 | 0.75 mg LY2189265n=231 | Exenatiden=210 |
|---|---|---|
| -0.37(0.12) | 0.18(0.12) | -0.28(0.12) |
| 1.5 mg LY2189265n=207 | 0.75 mg LY2189265n=195 | Exenatiden=202 | Placebon=78 |
|---|---|---|---|
| -46.82(1.81) | -42.09(1.87) | -37.48(1.83) | -18.07(2.68) |
| 1.5 mg LY2189265n=187 | 0.75 mg LY2189265n=185 | Exenatiden=178 |
|---|---|---|
| -43.84(2.07) | -40.62(2.12) | -36.16(2.11) |
| Measure | 1.5 mg LY2189265n=271 | 0.75 mg LY2189265n=269 | Exenatiden=266 | Placebon=119 |
|---|---|---|---|---|
| HbA1c Less Than 7% | 78.2 | 65.8 | 52.3 | 42.9 |
| HbA1c Less Than or Equal to 6.5% | 62.7 | 53.2 | 38.0 | 24.4 |
| Measure | 1.5 mg LY2189265n=271 | 0.75 mg LY2189265n=269 | Exenatiden=266 |
|---|---|---|---|
| HbA1c Less Than 7.0% | 70.8 | 59.1 | 49.2 |
| HbA1c Less Than or Equal to 6.5% | 57.2 | 48.3 | 34.6 |
| Measure | 1.5 mg LY2189265n=238 | 0.75 mg LY2189265n=218 | Exenatiden=223 | Placebon=98 |
|---|---|---|---|---|
| HOMA2-%B | 36.14(2.60) | 23.61(2.67) | 15.02(2.62) | 0.93(3.66) |
| HOMA2-%S | -3.14(2.91) | 1.16(2.97) | -1.59(2.92) | 2.56(4.07) |
| Measure | 1.5 mg LY2189265n=219 | 0.75 mg LY2189265n=202 | Exenatiden=187 |
|---|---|---|---|
| HOMA2-%B | 35.21(2.63) | 25.69(2.70) | 13.57(2.75) |
| HOMA2-%S | -7.48(2.93) | -5.49(3.01) | -3.75(3.07) |
| Measure | 1.5 mg LY2189265n=279 | 0.75 mg LY2189265n=280 | Exenatiden=276 | Placebon=141 |
|---|---|---|---|---|
| VAS Health State Score (n=270, 267, 264, 119) | 4.50(0.85) | 2.41(0.85) | 3.94(0.85) | 0.71(1.15) |
| EQ-5D UK (n=270, 266, 264, 119) | 0.01(0.01) | 0.01(0.01) | 0.00(0.01) | -0.00(0.02) |
The trial
How AWARD-1 was run
The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone.
- 1.5 mg LY2189265: LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks
- 0.75 mg LY2189265: LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks
- Exenatide: Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks
- Placebo: Placebo: subcutaneous (SC), once weekly for 26 weeks LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52). Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks
Who could join the trial
Inclusion Criteria: * Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications 1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication 2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications * Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day. * Willing to inject subcutaneous (SC) medication up to 2 times per day * Stable weight for 3 months prior to screening * Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m\^2) * Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test 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. Exclusion Criteria: * Type 1 Diabetes * HbA1c equal to or less than 6.5 before randomization or at randomization * Chronic insulin use * Taking drugs to promote weight loss by prescription or over the counter * Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled * History of fluid retention or edema * History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening * Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility * Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal * Acute or chronic pancreatitis of any form * Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 milliliters per minute (mL/min) * History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer * A serum calcitonin greater than or equal to 20 picograms per milliliter (pg/mL) at screening * Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis * History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years * Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing * Organ transplant except cornea * Have enrolled in another clinical trial within the last 30 days * Have previously signed an informed consent or participated in a LY2189265 (dulaglutide) study * Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
Published papers
Papers from AWARD-1
- Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
- 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.
- 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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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