drugset / Trial / NCT00596427

Mechanisms of Glucose Lowering Effect of Colesevelam HCl

NCT00596427 ↗

Completed 60 enrolled Carine Beysen
RandomizedParallel-groupDouble-blindBasic science

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.

Timeline

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

Outcome

Missed primary endpoint

paper Fasting endogenous glucose production and glycogenolysis significantly increased with placebo but were unchanged with colesevelam (treatment effect did not reach statistical significance). PMID 22134839 ↗

paper Colesevelam did not affect gluconeogenesis or appearance rate (absorption) of oral glucose. PMID 22134839 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Colesevelam Other / unclassified 625 mg —