Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine the effect of 8 weeks of treatment with colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the acute insulin response (AIRg) to an intravenous glucose load in subjects with prediabetes (impaired fasting glucose).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborator: VA Puget Sound Health Care System
• Treatments: Colesevelam Hydrochloride; Insulin

Criteria

Inclusion Criteria:

• Males or females (postmenopausal, surgically sterile or using double-barrier method of contraception), aged 18-75 years, FPG 100-115 mg/dl at screening (average of 2 measurements during screening; no individual measurement outside of the range 92-125 mg/dl)

• In good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis

• HbA1c <6.5% at screening

• Body mass index (BMI) in the range of 22-40 kg/m2 inclusive and with a stable (+/-2.5 kg) weight for the last 6 months

• Subjects must be willing to:

• Maintain prior exercise and dietary habits throughout the study

• Comply with all study requirements

• Provide written informed consent

Exclusion Criteria:

• Pregnant or lactating females

• Patients diagnosed with type 2 diabetes or that have taken glucose-lowering agents or insulin, except during pregnancy

• Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of treatment) within 8 weeks prior to screening

• HIV protease inhibitors

• Warfarin or phenytoin use

• Triglycerides >500 mg/dl

• History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection

• History of dysphagia, swallowing disorders or intestinal motility disorder

• History of pancreatitis

• Uncontrolled hypothyroidism

• Individuals with clinical hepatic disease or liver function tests greater than ≥2 times upper limits of normal within 30 days preceding the first dose of study drug

• On a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of study initiation

• Current or prior (within the past 3 months) treatment with a bile acid sequestrant (colesevelam, colestipol, colestimide, or cholestyramine)

• Use of any investigational drug in the last 30 days

• Donation of one unit (500 ml) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 weeks or a blood transfusion within 8 weeks prior to screening

• Employment by the research center