The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
562
Colesevelam 625 mg tablets
Placebo tablets appearing to be colesevelam
30 mg or 45 mg pioglitazone therapy
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in HbA1c at Week 4
Time frame: Baseline, Week 4
Change From Baseline in HbA1c at Week 8
Time frame: Baseline, Week 8
Change From Baseline in HbA1c at Week 16
Time frame: Baseline, Week 16
Number of Participants Achieving an HbA1c Goal of <7.0%
Time frame: Week 24
Change From Baseline in Fasting Plasma Glucose (FPG)
In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.
Time frame: Baseline, Week 24
Number of Participants With a Decrease of >= 0.7 Percent in HbA1c
Time frame: Week 24
Number of Participants With a Decrease of >= 0.5 Percent in HbA1c
Time frame: Week 24
Number of Participants With a Reduction in FPG of >= 30 mg/dL
Time frame: Week 24
Percent Change From Baseline in Total Cholesterol (TC)
TC is measured in milligrams per deciliter (mg/dL)
Time frame: Baseline, Week 24
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Montgomery, Alabama, United States
Unnamed facility
Montgomery, Alabama, United States
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Green Valley, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
Unnamed facility
Tempe, Arizona, United States
...and 131 more locations
LDL-C is measured in mg/dL
Time frame: Baseline, Week 24
Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
HDL-C is measured in mg/dL
Time frame: Baseline, Week 24
Percent Change From Baseline in Non-HDL-C
Non-HDL-C is measured in mg/dL
Time frame: Baseline, Week 24
Percent Change From Baseline in Triglycerides (TG)
TG are measured in mg/dL
Time frame: Baseline, Week 24
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)
Apo A-1 is measured in mg/dL
Time frame: Baseline, Week 24
Percent Change From Baseline in Apolipoprotein B (Apo B)
Apo B is measured in mg/dL
Time frame: Baseline, Week 24
Change From Baseline in Fasting Insulin Levels
Time frame: Baseline, Week 24
Change From Baseline in Fasting C-peptide
Time frame: Baseline, Week 24
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.
Time frame: Baseline, Week 24