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NCT01258075 · ClinicalTrials.gov registry record · Phase 4
Colesevelam for Children With Type 2 Diabetes
A Phase 4 study of Type 2 Diabetes Mellitus, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 4
- Development phase
- 236
- Enrollment target
- 20
- Study locations
NCT01258075: Completed Phase 4 study of Type 2 Diabetes Mellitus, sponsored by Daiichi Sankyo.
NCT01258075 is a Phase 4 study of Type 2 Diabetes Mellitus that has completed, run by Daiichi Sankyo. The registered enrollment target is 236 participants, below the 2,958-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01258075, a Phase 4 study of Type 2 Diabetes Mellitus, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 236 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5 chance of being assigned to the high-dose group. We believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.
Primary Outcome
The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Conditions Studied
Interventions
- DRUG High-dose colesevelam
- DRUG Low-dose colesevelam
Study Locations (20)
California
- - Los Angeles
- - Oakland
- - San Diego
Oklahoma
- - Oklahoma City
- - Oklahoma City
Arizona
- - Tucson
Arkansas
- - Little Rock
Colorado
- - Aurora
Connecticut
- - Hartford
Florida
- - Tampa
Georgia
- - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2011-02-24 |
| Est. Completion | 2020-04-21 |
| Phase | Phase 4 |
What the finished NCT01258075 record still lists
NCT01258075 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 2,958-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which High-dose colesevelam is the first listed.
NCT01258075 names 20 study sites across 17 states, led by California, Oklahoma, Arizona.
Frequently Asked Questions
What is clinical trial NCT01258075 about?
NCT01258075 is a clinical study titled "Colesevelam for Children With Type 2 Diabetes". This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have...
What is the current status of trial NCT01258075?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 236 participants. The study started on 2011-02-24. Estimated completion is 2020-04-21.
What conditions does trial NCT01258075 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT01258075?
The interventions under investigation include: High-dose colesevelam (DRUG), Low-dose colesevelam (DRUG).
Who is sponsoring clinical trial NCT01258075?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01258075 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
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 NCT01258075's enrollment target sits among peer trials
236 34th of 130 higher than 97 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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.
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