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Completed

NCT Number: NCT00147758

WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

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 sulfonylurea alone or in combination with other anti-diabetic drugs.

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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

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-75 years, inclusive
  • Diagnosed with type 2 diabetes
  • Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
  • Hemoglobin A1c value 7.5% to 9.5%, inclusive
  • C peptide > 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 < 60 mg/dL
  • Serum TG > 500 mg/dL
  • Body mass index (BMI) > 45 kg/m2

Treatment and study plan

Colesevelam hydrochloride

Drug

Primary outcomes

  1. To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy

Secondary outcomes

  1. To assess the fasting plasma glucose and fructosamine lowering efficacy;

  2. To assess glycemic control response rate;

  3. To assess the improvement in insulin sensitivity;

  4. To assess the effect on C reactive protein;

  5. To assess lipids and lipoproteins;

  6. To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy

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 Diabetics With Inadequate Glycemic Control on Sulfonylurea Monotherapy or Sulfonylurea Therapy in Combination With Other Oral Anti-Diabetic Agents

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 7, 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.

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