Status:
COMPLETED
Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
VA Puget Sound Health Care System
Conditions:
Impaired Fasting Glucose
Prediabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Colesevelam is a bile acid sequestrant that was initially approved for treatment of patients with dyslipidemia. Subsequently it was observed that patients with type 2 diabetes receiving this medicatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00990184
Start Date
September 1 2009
End Date
October 1 2010
Last Update
November 21 2012
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