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Completed Phase 4 Interventional Results available

Colesevelam for Children With Type 2 Diabetes

ClinicalTrials.gov ID: NCT01258075

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.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 12:32 AM EDT

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
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
236 participants

Conditions and interventions

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 24, 2011 (Actual)
Primary completion
Nov 1, 2019 (Actual)
Completion
Apr 21, 2020 (Actual)
Last update posted
May 13, 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 13, 2021 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01258075 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →