Trial · NCT01769378
Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)
NCT01769378, Phase 3, Completed, Eli Lilly and Company; results first posted 2015-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8). Trials, record NCT01769378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01769378
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)
- NCT number
- NCT01769378
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Placebo, Dulaglutide, Glimepiride
- First posted
- 2013-01-16
- Last updated
- 2016-01-25
- Results first posted
- 2015-10-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks | Baseline, 24 Weeks | Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML). |
| Secondary | Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks | 24 Weeks | The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation \[GEE\] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate. |
| Secondary | Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks | Baseline, 24 Weeks | LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF). |
| Secondary | Change From Baseline in Body Weight at 24 Weeks | Baseline, 24 Weeks | LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML. |
| Secondary | Change From Baseline in Body Mass Index (BMI) at 24 Weeks | Baseline, 24 Weeks | LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML. |
| Secondary | Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks | Baseline, 24 Weeks | LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML. |
| Secondary | Number of Participants With Reported and Adjudicated Cardiovascular Events | Baseline through 24 Weeks, 30-day Follow Up | Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module. |
| Secondary | Number of Participants With Adjudicated Acute Pancreatitis Events | Baseline through 24 Weeks, 30-day Follow Up | The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Secondary | Change From Baseline in Calcitonin at 24 Weeks | Baseline, 24 Weeks | |
| Secondary | Percentage of Participants With Self-Reported Events of Hypoglycemia | Baseline through 24 Weeks | Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =\<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =\<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks | Baseline, 24 Weeks | Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data at both baseline and post-baseline. | percent change of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks | 24 Weeks | Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and had evaluable FSG data at both baseline and post-baseline. LOCF was used to impute missing post-baseline values. If no data after date of randomization, the endpoint was considered missing. | milligrams per deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and had evaluable body weight data at both baseline and post-baseline. | kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and evaluable BMI data at both baseline and post-baseline. | kilograms per/square meter kg/m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and had evaluable SMPG data at both baseline and post-baseline. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Reported and Adjudicated Cardiovascular Events | Baseline through 24 Weeks, 30-day Follow Up | ITT population: All randomized participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated Acute Pancreatitis Events | Baseline through 24 Weeks, 30-day Follow Up | ITT population: all randomized participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Calcitonin at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and evaluable calcitonin data at baseline and post-baseline. | picogram per milliliter (pg/ml) | MEDIAN |
| SECONDARY | Percentage of Participants With Self-Reported Events of Hypoglycemia | Baseline through 24 Weeks | ITT Population: all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks | Dulaglutide | -1.38 | Standard Error 0.08 | percent change of HbA1c | |
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks | Placebo | -0.11 | Standard Error 0.14 | percent change of HbA1c | |
| Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks | Dulaglutide | Percent Achieved <7.0 HbA1c Level | 55.3 | percentage of participants | |
| Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks | Placebo | Percent Achieved <7.0 HbA1c Level | 18.9 | percentage of participants | |
| Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks | Dulaglutide | Percent Achieved ≤6.5 HbA1c Level | 40.0 | percentage of participants | |
| Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks | Placebo | Percent Achieved ≤6.5 HbA1c Level | 9.4 | percentage of participants | |
| Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks | Dulaglutide | -30.60 | Standard Error 4.46 | milligrams per deciliter (mg/dL) | |
| Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks | Placebo | 2.93 | Standard Error 6.76 | milligrams per deciliter (mg/dL) | |
| Change From Baseline in Body Weight at 24 Weeks | Dulaglutide | -0.91 | Standard Error 0.21 | kilograms (kg) | |
| Change From Baseline in Body Weight at 24 Weeks | Placebo | -0.24 | Standard Error 0.40 | kilograms (kg) |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dulaglutide | 240 | |
| Overall Study | STARTED | Placebo | 60 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Dulaglutide | 239 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 60 | |
| Overall Study | COMPLETED | Dulaglutide | 215 | |
| Overall Study | COMPLETED | Placebo | 56 | |
| Overall Study | NOT COMPLETED | Dulaglutide | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Dulaglutide | 20 | 239 | 30 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 60 | 0 |
| other | Eructation | Gastrointestinal disorders | Dulaglutide | 14 | 239 | 24 |
| other | Eructation | Gastrointestinal disorders | Placebo | 0 | 60 | 0 |
| other | Nausea | Gastrointestinal disorders | Dulaglutide | 25 | 239 | 31 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 60 | 0 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Dulaglutide | 1 | 239 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Placebo | 3 | 60 | 3 |
| serious | Angina pectoris | Cardiac disorders | Dulaglutide | 1 | 239 | 1 |
| serious | Angina pectoris | Cardiac disorders | Placebo | 0 | 60 | 0 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dulaglutide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dulaglutide | 44 | 239 |
| Total, other adverse events | Placebo | 3 | 60 |
| Total, serious adverse events | Dulaglutide | 9 | 239 |
| Total, serious adverse events | Placebo | 0 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36894938 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dulaglutide vs Placebo: Number of Participants With Adjudicated Acute Pancreatitis Events | Trial comparisons |
| Dulaglutide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01769378
GET https://conductscience.org/api/trials/v1/NCT01769378/results?page=2