What AWARD-8 measured first
| Dulaglutiden=215 | Placebon=53 |
|---|---|
| -1.38(0.08) | -0.11(0.14) |
A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8)
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks (percent change of HbA1c), Baseline, 24 Weeks. Dulaglutide: -1.38; Placebo: -0.11.
As posted on ClinicalTrials.gov (NCT01769378), updated at source Jan 25, 2016. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Dulaglutiden=215 | Placebon=53 |
|---|---|
| -1.38(0.08) | -0.11(0.14) |
Percent of participants affected. The most common events the registry lists.
| Event | Dulaglutide | Placebo |
|---|---|---|
| Any serious event | 3.8% | 0% |
| Nausea | 10.5% | 0% |
| Diarrhoea | 8.4% | 0% |
| Eructation | 5.9% | 0% |
| Hyperglycemia | 0.4% | 5% |
| Measure | Dulaglutiden=215 | Placebon=53 |
|---|---|---|
| Percent Achieved <7.0 HbA1c Level | 55.3 | 18.9 |
| Percent Achieved ≤6.5 HbA1c Level | 40.0 | 9.4 |
| Dulaglutiden=218 | Placebon=51 |
|---|---|
| -30.60(4.46) | 2.93(6.76) |
| Dulaglutiden=212 | Placebon=53 |
|---|---|
| -0.91(0.21) | -0.24(0.40) |
| Dulaglutiden=212 | Placebon=53 |
|---|---|
| -0.32(0.08) | -0.10(0.15) |
| Dulaglutiden=203 | Placebon=49 |
|---|---|
| -37.22(3.10) | -8.27(4.77) |
| Measure | Dulaglutiden=239 | Placebon=60 |
|---|---|---|
| Any reported CV events | 2 | 0 |
| Any adjudicated nonfatal CV events | 2 | 0 |
| Any confirmed adjudicated CV deaths | 0 | 0 |
| Dulaglutiden=239 | Placebon=60 |
|---|---|
| 0 | 0 |
| Dulaglutiden=215 | Placebon=59 |
|---|---|
| 0.00(0.00 to 0.00) | 0.00(0.00 to 0.00) |
| Measure | Dulaglutiden=239 | Placebon=60 |
|---|---|---|
| Symptomatic | 11.3 | 1.7 |
| Asymptomatic | 13.4 | 1.7 |
| Probable | 2.5 | 0.0 |
| Severe | 0 | 0 |
| Nocturnal | 6.7 | 1.7 |
| Measure | Dulaglutiden=239 | Placebon=60 |
|---|---|---|
| Total HE | 0.19(0.59) | 0.01(0.03) |
| Documented symptomatic HE | 0.07(0.33) | 0.00(0.02) |
| Asymptomatic HE | 0.11(0.45) | 0.00(0.02) |
| Severe HE | 0(0.0) | 0(0.0) |
| Nocturnal HE | 0.02(0.16) | 0.00(0.02) |
| Probable symptomatic HE | 0.01(0.04) | 0(0.0) |
| Dulaglutiden=239 | Placebon=60 |
|---|---|
| 2.1 | 11.7 |
| Dulaglutiden=239 | Placebon=60 |
|---|---|
| 22.59(0.36) | 22.47(0.66) |
The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy.
Inclusion Criteria: * Type 2 diabetes mellitus * Stable dose of sulfonylurea that is at least 50% of the maximum approved dose per the local label for at least 3 months prior to the first study visit * Have an HbA1c value of ≥7.5% and ≤9.5%, as determined by the central laboratory draw performed at the first study visit * Accept continued treatment with sulfonylurea therapy, throughout the trial, as required per protocol * Men and nonpregnant women aged ≥18 years * Stable weight (±5%) ≥3 months prior to screening * Body Mass Index (BMI) ≤45 kilograms per square meter (kg/m\^2) Exclusion Criteria: * Have type 1 diabetes mellitus * Have been treated with ANY other antihyperglycemic medications (other than sulfonylurea) at the time of the first study visit or within 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 within 3 months prior to the first study visit is exclusionary * Have been treated with drugs that promote weight loss within 3 months prior to the first study visit * Are receiving chronic (\>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 (CV) 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 (eg, 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 \>2.5 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 an estimated glomerular filtration rate \[eGFR\] \<30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2), calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation as determined by the central laboratory at the first study visit * Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) 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 hyperplasia, focal hyperplasia,...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.