Colesevelam for Children With Type 2 Diabetes
Public ClinicalTrials.gov record NCT01258075. 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
Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01258075
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 236 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 17 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
- Feb 23, 2011
- Primary completion
- Oct 31, 2019
- Completion
- Apr 20, 2020
- Last update posted
- May 12, 2021
2011 – 2020
United States locations
- U.S. sites
- 24
- U.S. states
- 19
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Tucson | Arizona | 85724 | — |
| Not listed | Little Rock | Arkansas | 72202 | — |
| Not listed | Los Angeles | California | 90027 | — |
| Not listed | Oakland | California | 94609 | — |
| Not listed | San Diego | California | 92123 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Hartford | Connecticut | 06106 | — |
| Not listed | Tampa | Florida | 33612 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Kansas City | Kansas | 66160 | — |
| Not listed | Baltimore | Maryland | 21229 | — |
| Not listed | Springfield | Massachusetts | 01199 | — |
| Not listed | New York | New York | 10032 | — |
| Not listed | Raleigh | North Carolina | 27610 | — |
| Not listed | Cincinnati | Ohio | 45229 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Oklahoma City | Oklahoma | 73112 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Greenville | South Carolina | 29615 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Dallas | Texas | 75235 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | San Antonio | Texas | 78207 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01258075, 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 May 12, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01258075 live on ClinicalTrials.gov.