Phase 3
Completed N=21
Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
Source: ClinicalTrials.gov NCT00990184 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Nov 2012
Primary outcomePrimary: Acute Insulin Response (AIRg) to Intravenous Glucose — 1866; 1752 pmol/1*min
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Insulin Response (AIRg) to Intravenous Glucose |
1866; 1752 | — |
| SECONDARY Insulin Sensitivity |
4.6; 4.8 | — |
| SECONDARY Glucose Disappearance Rate |
1.32; 1.26 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00990184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.