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Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

NCT00993824 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-11-30

Study results available
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Summary

The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.

Conditions

Interventions

DRUG

colesevelam HCl

3.75 grams of colesevelam HCl (6 tablets)

DRUG

placebo

Sponsors & Collaborators

  • International Diabetes Center at Park Nicollet

    collaborator OTHER

  • Daiichi Sankyo

    collaborator INDUSTRY

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Roger S. Mazze, PhD · International Diabetes Center at Park Nicollet

  • Elinor S. Strock, APRN, BC · International Diabetes Center at Park Nicollet

  • Robert M. Cuddihy, MD · International Diabetes Center at Park Nicollet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00993824 on ClinicalTrials.gov