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.
Public ClinicalTrials.gov record NCT00570739. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effects of Metformin HCl in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, as Initial Therapy in Drug naïve Subjects With Type 2 Diabetes Mellitus, and the Effects of Colesevelam HCl on the Lipid Profile in Subjects With Pre Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00570739
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 502 participants
Conditions and interventions
Interventions
- Metformin HCl and Colesevelam Placebo Drug
- Metformin HCl tablets and Colesevelam tablets Drug
- Colesevelam placebo Drug
- Colesevelam Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2007 (Type not available)
- Primary completion
- Apr 2009 (Actual)
- Completion
- May 2009 (Actual)
- Last update posted
- Jul 27, 2010
2007 – 2009
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Los Gatos | California | — | — |
| Not listed | Tarzana | California | — | — |
| Not listed | Ocala | Florida | — | — |
| Not listed | Pocatello | Idaho | — | — |
| Not listed | Gary | Indiana | — | — |
| Not listed | New Orleans | Louisiana | 70112 | — |
| Not listed | Olive Branch | Mississippi | — | — |
| Not listed | Dundee | New York | — | — |
| Not listed | West Seneca | New York | — | — |
| Not listed | Statesville | North Carolina | — | — |
| Not listed | Kent | Ohio | — | — |
| Not listed | Marion | Ohio | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Corpus Christi | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00570739, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2010 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00570739 live on ClinicalTrials.gov.