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NCT00570739 · ClinicalTrials.gov registry record · Phase 3
Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 502
- Enrollment target
NCT00570739: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT00570739 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 502 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00570739, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 502 participants
- Enrollment target
Study Summary
This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be be enrolled. Qualified subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or metformin HCl plus placebo matching colesevelam HCl. Qualified pre-diabetic subjects will be randomized 1:1 to receive colesevelam HCl or matching placebo.
Interventions
- DRUG Colesevelam
- DRUG Metformin HCl and Colesevelam Placebo
- DRUG Metformin HCl tablets and Colesevelam tablets
- DRUG Colesevelam placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2007-11 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT00570739 record still lists
NCT00570739 is an interventional study that assigns participants to a tested intervention. The registered 502 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 (35% lower).
The record links to 0 conditions, and to 4 interventions - of which Colesevelam is the first listed.
NCT00570739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00570739 about?
NCT00570739 is a clinical study titled "Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.". This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with type 2 diabetes (T2DM) and 2...
What is the current status of trial NCT00570739?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 502 participants. The study started on 2007-11. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00570739?
The interventions under investigation include: Colesevelam (DRUG), Metformin HCl and Colesevelam Placebo (DRUG), Metformin HCl tablets and Colesevelam tablets (DRUG), Colesevelam placebo (DRUG).
Who is sponsoring clinical trial NCT00570739?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00570739's enrollment target sits among peer trials
502 743rd of 2000 higher than 1,258 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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