What AWARD-9 measured first
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| -1.44(0.09) | -0.67(0.09) |
A Randomized, Double-Blind Trial Comparing the Effect of Dulaglutide 1.5 mg With Placebo on Glycemic Control in Patients With Type 2 Diabetes on Basal Insulin Glargine
Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c) (percentage of change), Baseline, 28 Weeks. Dulaglutide + Insulin Glargine: -1.44; Placebo + Insulin Glargine: -0.67.
As posted on ClinicalTrials.gov (NCT02152371), updated at source Sep 25, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| -1.44(0.09) | -0.67(0.09) |
Percent of participants affected. The most common events the registry lists.
| Event | Dulaglutide + Insulin Glargine | Placebo + Insulin Glargine |
|---|---|---|
| Any serious event | 6% | 4.7% |
| Nausea | 12% | 1.3% |
| Diarrhoea | 11.3% | 4% |
| Nasopharyngitis | 4% | 9.3% |
| Upper respiratory tract infection | 7.3% | 6.7% |
| Decreased appetite | 6.7% | 0% |
| Dyspepsia | 6% | 0% |
| Vomiting | 6% | 0% |
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| -44.63(4.16) | -27.90(4.08) |
| Measure | Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|---|
| Pre-Morning Meal (n=133,129) | -44.03(2.71) | -35.97(2.64) |
| Morning Meal 2-Hour Postprandial (n=123,119) | -64.16(4.31) | -46.97(4.27) |
| Pre-Midday Meal (n=133,127) | -40.89(3.72) | -25.34(3.62) |
| Midday Meal 2-Hour Post Prandial (n=123,117) | -51.13(4.40) | -32.98(4.33) |
| Pre-Evening Meal (n=133,129) | -43.68(4.21) | -28.71(4.07) |
| Evening Meal 2-Hour Postprandial (n=126,122) | -48.63(5.22) | -27.35(5.16) |
| 3:00 AM (Morning) (n=124,117) | -39.77(4.27) | -20.30(4.23) |
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| -1.91(0.30) | 0.50(0.30) |
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| 12.75(2.27) | 25.94(2.30) |
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| 3 | 1 |
| Measure | Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|---|
| Symptomatic | 35.3 | 30.0 |
| Asymptomatic | 42.7 | 39.3 |
| Severe | 0.7 | 0.0 |
| Nocturnal | 28.0 | 28.7 |
| Probable Symptomatic | 2.7 | 2.0 |
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| 0 | 0 |
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| 0 | 0 |
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| 1 | 0 |
| Dulaglutide + Insulin Glarginen=149 | Placebo + Insulin Glarginen=149 |
|---|---|
| 0 | 2 |
| Measure | Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|---|
| HbA1c <= 6.5 | 50.7 | 16.7 |
| HbA1c < 7.0 | 69.3 | 35.3 |
| Dulaglutide + Insulin Glarginen=150 | Placebo + Insulin Glarginen=150 |
|---|---|
| 40.7 | 16.7 |
The main purpose of this study is to evaluate the use of the study drug known as dulaglutide in participants with type II diabetes who are taking once-daily insulin glargine. The study will last about 31 weeks for each participant.
Inclusion Criteria: * Have type 2 diabetes (based on the World Health Organization's \[WHO\] diagnostic criteria) * Have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening * Doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (≥1500 mg/day) and the maximum approved dose per the locally-approved label * Have an HbA1c value ≥7.0% and ≤10.5% as assessed by the central laboratory at screening * Require further insulin glargine dose increase at week 3 per the treat-to-target (TTT) algorithm based on the SMPG data collected during the prior week * Have stable weight (±5%) ≥3 months prior to screening * Have body mass index (BMI) ≤45 kilograms per square meter (kg/m\^2) at screening * Are able and willing to administer once weekly randomized therapy * Are females of childbearing potential who must: * Test negative for pregnancy at screening, based on a serum pregnancy test * Agree to use a reliable method of birth control * Not be breastfeeding Exclusion Criteria: * Have been treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with or without metformin, within the 3 months prior to screening or between screening and week 3 * Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma * Have a history of hypoglycemia unawareness within the 6 months prior to screening * Have been treated with drugs that promote weight loss within the 3 months prior to screening or between screening and week 3 * Are receiving chronic (\>14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks prior to screening or between screening and week 3 * Have had any of the following cardiovascular conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke) * Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery * Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory * Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening * Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter (mL/min/m\^2), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory; for participants on metformin, have renal disease or renal dysfunction (for example, a serum...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.