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

NCT00990184 | Completed Phase 3 Results DMC

• 1 other identifier: 1.2
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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 (AIRg) to an intravenous glucose load in subjects with prediabetes (impaired fasting glucose).

Conditions

Impaired Fasting Glucose; Prediabetes

Keywords

Impaired Fasting Glucose; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Acute Insulin Response (AIRg) to Intravenous Glucose

  Increase in insulin following glucose injection. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection calculated over the 10 minutes following glucose administration.

  Baseline and 8 weeks

Secondary Outcomes (2)

• Insulin Sensitivity

  Baseline and 8 weeks

• Glucose Disappearance Rate

  Baseline and 8 weeks

Study Arms (1)

Colesevelam Hydrochloride

EXPERIMENTAL

Drug: Colesevelam; Other: placebo

Interventions

Colesevelam DRUG

colesevelam HCl 3.75 g once daily orally with the evening meal

Also known as: colesevelam HCl

Colesevelam Hydrochloride

placebo OTHER

tablet (s) orally given with evening meal

Colesevelam Hydrochloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• VA Puget Sound Health Care System: collaborator

Related Publications (1)

• Marina AL, Utzschneider KM, Wright LA, Montgomery BK, Marcovina SM, Kahn SE. Colesevelam improves oral but not intravenous glucose tolerance by a mechanism independent of insulin sensitivity and beta-cell function. Diabetes Care. 2012 May;35(5):1119-25. doi: 10.2337/dc11-2050. Epub 2012 Mar 23.

  PMID: 22446171 DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Results Point of Contact

• Title: Steven E. Kahn
• Organization: SIBCR

skahn@u.washington.edu

206-277-5515

Study Officials

• Steven E Kahn, MB CHB

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 6, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 21, 2012
• Results First Posted: November 21, 2012

Record last verified: 2012-10