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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 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 502 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00570739
The ClinicalTrials.gov registry entry for NCT00570739 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 502 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Colesevelam is the first listed.
NCT00570739 reports 0 study locations.
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.
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