Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147745
• Other study ID #: WEL-201
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: March 5, 2014
• Start date: June 2005
• Est. completion date: January 2008

Study information

• Verified date: March 2014
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 18 - 75, inclusive

• Diagnosed with type 2 diabetes

• Hemoglobin A1c value greater than or equal to 8.0%

• Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)

• Overweight, obese (body mass index 25-45 kg/m2)

Exclusion Criteria:

• Change of dose of lipid or blood pressure lowering therapy within past three months

• Previous treatment with colesevelam for hyperlipidemia

• Serum triglyceride greater than 500 mg/dL

• Serum low density lipoprotein-cholesterol less than 60 mg/dL

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Colesevelam
Colesevelam 3.8g for 12 weeks
• Colesevelam matching placebo
Colesevelam matching placebo for 12 weeks
• Insulin glargine (Lantus)
Insulin glargine for 12 weeks

Locations

Country	Name	City	State
United States	San Diego VMC	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.	The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin.	Baseline to 12 weeks	No
Primary	Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.	The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin.	Baseline to 12 weeks	No
Primary	Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose	Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.	Baseline (Day -4) to first dose (Day 1)	No
Secondary	The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks	The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption.	Baseline to 12 weeks	No
Secondary	Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks	The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.	Baseline to 12 weeks	No