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NCT01769378 · ClinicalTrials.gov registry record · Phase 3
Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT01769378: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01769378 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769378, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG Dulaglutide
- DRUG Glimepiride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01769378 record still lists
NCT01769378 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01769378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01769378 about?
NCT01769378 is a clinical study titled "Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)". 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.
What is the current status of trial NCT01769378?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2013-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01769378?
The interventions under investigation include: Placebo (DRUG), Dulaglutide (DRUG), Glimepiride (DRUG).
Who is sponsoring clinical trial NCT01769378?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01769378's enrollment target sits among peer trials
300 1122nd of 2000 higher than 840 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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