Status:
COMPLETED
Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Diabetes Mellitus, Type 1
Hyperlipidemias
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00938405
Start Date
July 1 2009
End Date
December 1 2009
Last Update
May 20 2014
Active Locations (1)
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1
Barbara Davis Center for Diabetes
Aurora, Colorado, United States, 80045