Expired Study
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Clinical Trial 9409

Burbank, CA 91505

Study 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
• 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
• Have an A1C >= 7.5% and =< 9.5% at screening
• Have a fasting plasma glucose =<240 mg/dL at randomization (Week0/Day 1)
• Be atleast 18 years of age
• If a women of childbearing potential (WOCBP), be using an adequate method of contraception as detailed per-protocol
• Have a fasting C-peptide level >0.5 ng/mL at screening
• Be clinically stable for all medical conditions other than type 2 diabetes
• 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.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.