WelChol® and Insulin 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 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy Combination With Other Oral Anti-diabetic Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151749
• Other study ID #: WEL-302
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: January 16, 2012
• Start date: June 2004
• Est. completion date: December 2005

Study information

• Verified date: January 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: 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 WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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-

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
Primary	addition of WelChol® to current antidiabetic therapy
Secondary	To assess: the effects on fasting plasma glucose and
Secondary	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-
Secondary	on therapy to patients receiving insulin alone or with
Secondary	other oral drugs