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NCT01966978 · ClinicalTrials.gov registry record · Phase 4
The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 157
- Enrollment target
NCT01966978: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT01966978 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 157 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01966978, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 157 participants
- Enrollment target
Study Summary
The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c \> 10%).
Primary Outcome
Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy
Interventions
- DRUG Metformin
- DRUG Liraglutide
- DRUG Detemir
- DRUG Insulin Aspart
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2014-11 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
What the finished NCT01966978 record still lists
NCT01966978 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT01966978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01966978 about?
NCT01966978 is a clinical study titled "The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study". The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c \> 10%).
What is the current status of trial NCT01966978?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 157 participants. The study started on 2014-11. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01966978?
The interventions under investigation include: Metformin (DRUG), Liraglutide (DRUG), Detemir (DRUG), Insulin Aspart (DRUG).
Who is sponsoring clinical trial NCT01966978?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01966978's enrollment target sits among peer trials
157 519th of 2000 higher than 1,480 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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