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Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin
NCT00484419 · View on ClinicalTrials.gov ↗
Study Summary
A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.
Conditions Studied
Interventions
- DRUG Colesevelam HCl
- DRUG rosiglitazone maleate
- DRUG sitagliptin phosphate
Study Locations (20)
California
- — La Mesa
- — Los Angeles
- — Los Gatos
- — San Antonio
Michigan
- — Dearborn
- — West Bloomfield
North Carolina
- — Lexington
- — Winston-Salem
Ohio
- — Munroe Falls
- — Zaneville
Florida
- — Chiefland
Indiana
- — Gary
Maryland
- — Baltimore
Nevada
- — Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00484419
The ClinicalTrials.gov registry entry for NCT00484419 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 3 interventions — of which Colesevelam HCl is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00484419 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Michigan, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00484419 about?
NCT00484419 is a clinical study titled "Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin". A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.
What is the current status of trial NCT00484419?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2007-05. Estimated completion is 2008-04.
What conditions does trial NCT00484419 study?
This clinical trial studies the following conditions: Type 2 Diabetes, Hyperlipidemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00484419?
The interventions under investigation include: Colesevelam HCl (DRUG), rosiglitazone maleate (DRUG), sitagliptin phosphate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00484419?
This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00484419 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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