Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 562
Healthy volunteers: no

Brief summary:
The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.

Detailed description:

Arms:
arm 1: Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg) arm 2: Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)

Interventions: intervention 1: Colesevelam intervention 2: Placebo intervention 3: Pioglitazone
Intervention descriptions: intervention 1: Colesevelam 625 mg tablets intervention 2: Placebo tablets appearing to be colesevelam intervention 3: 30 mg or 45 mg pioglitazone therapy

Protocol document: