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NCT00484419 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Type 2 Diabetes and Hyperlipidemia, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 169
- Enrollment target
- 20
- Study locations
NCT00484419: Completed Phase 3 study of Type 2 Diabetes and Hyperlipidemia, sponsored by Daiichi Sankyo.
NCT00484419 is a Phase 3 study of Type 2 Diabetes and Hyperlipidemia that has completed, run by Daiichi Sankyo. The registered enrollment target is 169 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00484419, a Phase 3 study of Type 2 Diabetes and Hyperlipidemia, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 169 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.
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 |
What the finished NCT00484419 record still lists
NCT00484419 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (96% lower).
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.
NCT00484419 names 20 study sites across 14 states, led by California, Michigan, North Carolina.
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.
What interventions are being tested in trial NCT00484419?
The interventions under investigation include: Colesevelam HCl (DRUG), rosiglitazone maleate (DRUG), sitagliptin phosphate (DRUG).
Who is sponsoring clinical trial NCT00484419?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00484419's enrollment target sits among peer trials
169 109th of 327 higher than 219 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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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