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Colesevelam for Children With Type 2 Diabetes

NCT01258075 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2021-05-13

Study results available
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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.

Conditions

Interventions

DRUG

High-dose colesevelam

3.75 grams colesevelam hydrochloride in oral suspension

DRUG

Low-dose colesevelam

0.625 grams colesevelam hydrochloride in oral suspension

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader/Medical Monitor · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-24
Primary Completion
2019-11-01
Completion
2020-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01258075 on ClinicalTrials.gov