Skip to main content
OpenTrials
Completed

NCT Number: NCT00151749

WelChol® and Insulin in Treating Patients With Type 2 Diabetes

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mexico City, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18 - 75 years, inclusive
  • Diagnosed with type 2 diabetes
  • Stable insulin therapy for 6 weeks
  • Stable dose of any other antidiabetic medications for 90 days
  • Hemoglobin A1c value between 7.5% to 9.5%
  • C peptide greater than 0.5 ng/mL
  • Prescribed ADA diet

Exclusion criteria

  • History of type 1 diabetes or ketoacidosis
  • History of pancreatitis
  • Uncontrolled hypertension
  • Allergy or toxic response to colesevelam or any of its components
  • Serum LDL-C less than 60 mg/dL
  • Serum TG greater than 500 mg/dL
  • Body mass index (BMI) greater than 45 kg/m2-

Treatment and study plan

Colesevelam hydrochloride

Drug

Primary outcomes

  1. - To assess the additional lowering of HbA1c achieved by

  2. addition of WelChol® to current antidiabetic therapy

Secondary outcomes

  1. To assess: the effects on fasting plasma glucose and

  2. fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-

  3. on therapy to patients receiving insulin alone or with

  4. other oral drugs

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy Combination With Other Oral Anti-diabetic Agents

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 9, 2005
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.