Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1, Hyperlipidemias
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring type 1 diabetes mellitus, colesevelam, LDL, cholesterol, A1c, target range glucose values
Eligibility Criteria
Inclusion Criteria:
- All subjects will be on stable doses of insulin using MDI or CSII (Basal insulin- Lantus or Levemir; Bolus- Humalog, Novolog, Apidra, Humulin Regular), for three months prior to enrollment.
- Type 1 diabetes duration > 3 years.
- 6.5% ≤ A1c ≤ 9.0%.
- Male or female ≥ 18 and ≤ 65 years of age.
- Ability and willingness to adhere to the protocol including multiple daily oral doses of study drug or placebo and week-long CGM wear.
- LDL-C > 100 mg/dl.
- Willing to adhere to colesevelam dosage instructions, including administration of drugs with a known interaction at least 4 hours prior to colesevelam. Females using oral contraceptives containing ethinyl estradiol and norethindrone must be willing to administer their doses at least four hours prior to using colesevelam.
Exclusion Criteria:
- Advanced retinopathy needing laser procedure or vitrectomy.
- Unstable nephropathy (serum creatinine > 2.0 mg/dl or macroproteinuria (albumin excretion rate > 200 ug/ min).
- Any unexplained severe hypoglycemia within the last six months.
- BMI > 35.0.
- Currently on a pre-existing bile acid sequestrant therapy, glyburide, levothyroxine, phenytoin, or warfarin.
- Pregnant, planning a pregnancy, or not using an adequate method of birth control.
- Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent.
- Use of any medication known to modify glucose values other than insulin (i.e. corticosteroids or oral antidiabetics).
- A history of bowel obstruction.
- Serum triglyceride (TG) concentrations >500 mg/dL.
- A history of hypertriglyceridemia induced pancreatitis.
Sites / Locations
- Barbara Davis Center for Diabetes
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Colesevelam HCl
Comparison group
Beginning at Visit 1, two weeks after screening, subjects in the active treatment group will take 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.
Beginning at Visit 1, two weeks after screening, subjects in the comparison group will be administered placebo, taking 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.