Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00938405
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00938405
Study Brief:
Protocol Section:
NCT00938405