Summary:
Do you have Type 2 Diabetes and are you taking Actos (pioglitazone)? We currently have a study that investigates Welchol as add-on therapy to pioglitazone to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with pioglitazone alone or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if Welchol add-on to pioglitazone therapy for Type 2 Diabetes Mellitus will be safe, well tolerated, and efficacious.
Qualified Participants Must:
• Have a diagnosis of Type 2 Diabetes Mellitus
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Have inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications (metformin or a sulfonylurea. or DPP-IV inhibitor
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Have an A1C >= 7.5% and =< 9.5% at screening
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Have a fasting plasma glucose =<240 mg/dL at randomization (Week0/Day 1)
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Be atleast 18 years of age
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If a women of childbearing potential (WOCBP), be using an adequate method of contraception as detailed per-protocol
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Have a fasting C-peptide level >0.5 ng/mL at screening
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Be clinically stable for all medical conditions other than type 2 diabetes
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Be taking any other medications at stable doses for at least 30 days prior to enrollment, and not anticipated to need adjustment during the study period
Qualified Participants May Receive:
Study related care, diagnostic tests, and study medication at no cost. Payment for time and travel to the study center may be provided.