WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147758
• Other study ID #: WEL-303
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: January 16, 2012
• Start date: June 2004
• Est. completion date: August 2006

Study information

• Verified date: January 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPeru: General Directorate of Pharmaceuticals, Devices, and DrugsMexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Colesevelam hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
Secondary	To assess the fasting plasma glucose and fructosamine lowering efficacy;
Secondary	To assess glycemic control response rate;
Secondary	To assess the improvement in insulin sensitivity;
Secondary	To assess the effect on C reactive protein;
Secondary	To assess lipids and lipoproteins;
Secondary	To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy