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Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus

NCT00938405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-05-20

No results posted yet for this study

Summary

This is a prospective, randomized, double blind, parallel, placebo controlled clinical trial evaluating the efficacy of colesevelam HCl in reducing LDL in subjects with type 1 diabetes mellitus over a 12 week treatment period. The aim is to highlight the effect of colesevelam on LDL cholesterol and glycemia in a type 1 diabetic population. The colesevelam group is anticipated to demonstrate a mean reduction in LDL by 10% compared to the placebo group, indicated by A1c and glycemic target range CGM readings.

Conditions

  • Diabetes Mellitus, Type 1
  • Hyperlipidemias

Interventions

DRUG

Colesevelam HCl

3.75 gms/day of colesevelam HCl in the form of three 625 mg tablets with lunch and dinner or six 625mg tablets once daily with dinner.

DRUG

Placebo

Placebo: 3.75 gms/day in the form of three 625 mg tablets with lunch and dinner or six 625mg tablets once daily with dinner.

Sponsors & Collaborators

  • Daiichi Sankyo

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Satish K Garg, MD · University of Colorado Denver/ Barbara Davis Center for Diabetes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00938405 on ClinicalTrials.gov