Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
Condition: Impaired Fasting Glucose; Prediabetes
MeSH terms: Insulin Resistance; Prediabetic State; Glucose Intolerance
Intervention: Colesevelam; placebo
Intervention description: colesevelam HCl 3.75 g once daily orally with the evening meal; tablet (s) orally given with evening meal
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Impaired Fasting Glucose; PreDiabetes

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).
    

Eligibility 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