WelChol® With Metformin in Treating Patients With Type 2 Diabetes

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147719

Enrollment

300

Registered

2005-09-07

Start date

2004-06-30

Completion date

2006-07-31

Last updated

2012-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes Mellitus

Brief summary

The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.

Interventions

DRUGColesevelam hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age 18-75 years, inclusive * Diagnosed with type 2 diabetes * Hemoglobin (HbA1c) between 7.5% to 9.5% * Prescribed an ADA accepted diet * Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1

Exclusion criteria

* History of type 1 diabetes or ketoacidosis * History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment * History of pancreatitis * Uncontrolled hypertension * Recent severe cardiovascular disease * Allergy or toxic response to colesevelam or any of its components * Body mass index (BMI) \>45 kg/m2

Design outcomes

Primary

Measure	Time frame
To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy	—

Secondary

Measure	Time frame
To assess the glycemic control response rate;	—
To assess the improvement in insulin sensitivity;	—
To assess the fasting plasma glucose and fructosamine lowering effect;	—
To assess the improvement in lipids, and lipoproteins;	—
To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy	—
To assess the effect on high sensitivity C-reactive protein;	—

Countries

Mexico, Peru, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026