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 sulfonylurea alone or in combination with other anti-diabetic drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
To assess the additional lowering of HbA1c achieved by addition of colesevelam hydrochloride to current antidiabetic therapy
To assess the fasting plasma glucose and fructosamine lowering efficacy;
To assess glycemic control response rate;
To assess the improvement in insulin sensitivity;
To assess the effect on C reactive protein;
To assess lipids and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy
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Birmingham, Alabama, United States
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Tuscumbia, Alabama, United States
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Little Rock, Arkansas, United States
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Searcy, Arkansas, United States
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Concord, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Gatos, California, United States
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West Hills, California, United States
...and 37 more locations