Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1; Hyperlipidemias
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hyperlipidemias
Study type: Interventional

Summary: 
      This is a prospective, randomized, double blind, parallel, placebo controlled clinical trial
      evaluating the efficacy of colesevelam HCl in reducing LDL in subjects with type 1 diabetes
      mellitus over a 12 week treatment period. The aim is to highlight the effect of colesevelam
      on LDL cholesterol and glycemia in a type 1 diabetic population. The colesevelam group is
      anticipated to demonstrate a mean reduction in LDL by 10% compared to the placebo group,
      indicated by A1c and glycemic target range CGM readings.
    

Detailed description: 
      This is a prospective, randomized, double blind, parallel, placebo controlled clinical trial
      evaluating the efficacy of colesevelam HCl in reducing LDL in subjects with type 1 diabetes
      mellitus over a 12 week treatment period. Colesevelam is an orally administered bile acid
      sequestrant approved as an adjunct for diet and exercise for lowering incidence of
      hyperlipidemia, an important risk factor for long term cardiovascular health in the general
      population and people living with diabetes. Use of colesevelam has been shown to concurrently
      decrease low density lipoprotein cholesterol (LDL-C) and A1c in patients with type 2
      diabetes. The exact mechanism is unknown. Our research aims to highlight the effect of
      colesevelam on LDL and glycemia in a type 1 diabetic population.

      This single-center study will enroll a maximum of 40 patients with LDL-C > 100 and A1c values
      between 6.5-9%, who will be randomized in a 1:1 fashion to either the study drug or placebo.
      Visits will be conducted at screening, baseline, one month, two months, and three months. At
      home, subjects will take 3.75 gms/day of colesevelam HCl or placebo throughout the study
      duration. Laboratory analysis will be performed at various timepoints assessing A1c, fasting
      lipid panel, c-peptide, glucagon-like-peptide-1 (GLP-1), and glucose-dependent insulinotropic
      peptide (GIP). Continuous glucose monitoring (CGM) measurements will be obtained on all
      patients for one week before each monthly visit to assess for above target range (ATR),
      within target range (WTR), and below target range (BTR) glucose values and time spent in
      hyperglycemic and hypoglycemic excursions.

      The colesevelam group is anticipated to demonstrate a mean reduction in LDL by 10% compared
      to the placebo group.
    

Intervention name(s): Colesevelam HCl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3.75 gms/day of colesevelam HCl in the form of three 625 mg tablets with lunch and dinner or six 625mg tablets once daily with dinner.; Placebo: 3.75 gms/day in the form of three 625 mg tablets with lunch and dinner or six 625mg tablets once daily with dinner.
Other intervention name(s): WELCHOL (colesevelam hydrochloride); Initial U.S. Approval: 2000
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 1 diabetes mellitus; colesevelam; LDL; cholesterol; A1c; target range glucose values