Overview

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