WelChol® With Metformin in Treating Patients With Type 2 Diabetes
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age 18-75 years, inclusive
Diagnosed with type 2 diabetes
Hemoglobin (HbA1c) between 7.5% to 9.5%
Prescribed an ADA accepted diet
Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1
History of type 1 diabetes or ketoacidosis
History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
History of pancreatitis
Recent severe cardiovascular disease
Allergy or toxic response to colesevelam or any of its components