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Mechanisms of Glucose Lowering Effect of Colesevelam HCl

NCT00596427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-10-12

Study results available
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Summary

The mechanism by which colesevelam HCl lowers glucose is not known. Knowledge of the potential mechanism of action is important for defining the role of the drug among oral antidiabetic agents available for use in subjects with diabetes. The objective of this study is to provide insight into the mechanisms of action of colesevelam HCl in T2DM. The mechanisms of interest include hepatic insulin sensitivity, rate of appearance of exogenous glucose and changes in incretin hormone concentrations.

Conditions

Interventions

DRUG

Colesevelam HCL

Colesevelam HCL 625 mg: 3 tablets twice per day

DRUG

Placebo

Placebo tablets: 3 tablets twice per day

Sponsors & Collaborators

  • Carine Beysen

    lead INDUSTRY

Principal Investigators

  • Carine Beysen, PhD · KineMed

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00596427 on ClinicalTrials.gov