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NCT01621178 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 577
- Enrollment target
NCT01621178: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01621178 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 577 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621178, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 577 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease.
Primary Outcome
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment\*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and pa
Interventions
- DRUG Insulin glargine
- DRUG Dulaglutide
- DRUG Insulin lispro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 577 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT01621178 record still lists
NCT01621178 is an interventional study that assigns participants to a tested intervention. The registered 577 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 (25% lower).
The record links to 0 conditions, and to 3 interventions - of which Insulin glargine is the first listed.
NCT01621178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01621178 about?
NCT01621178 is a clinical study titled "A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)". The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease.
What is the current status of trial NCT01621178?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 577 participants. The study started on 2012-07. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01621178?
The interventions under investigation include: Insulin glargine (DRUG), Dulaglutide (DRUG), Insulin lispro (DRUG).
Who is sponsoring clinical trial NCT01621178?
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 NCT01621178's enrollment target sits among peer trials
577 661st of 2000 higher than 1,340 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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