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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
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 effect;
To assess the glycemic control response rate;
To assess the improvement in insulin sensitivity;
To assess the effect on high sensitivity C-reactive protein;
To assess the improvement in lipids, and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy
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CRO
Jonesboro, Arkansas, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Carmichael, California, United States
Unnamed facility
Fresno, California, United States
Unnamed facility
Irvine, California, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Los Gatos, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Spring Valley, California, United States
Unnamed facility
West Hills, California, United States
...and 38 more locations