This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5 chance of being assigned to the high-dose group. We believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.
Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM) to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have been treated with Metformin or have had no antidiabetic drug treatment in the previous three months. Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well tolerated, and shows improved blood sugar control (as evidenced by a significant change from baseline in hemoglobin A1C \[HbA1c\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
236
3.75 grams colesevelam hydrochloride in oral suspension
0.625 grams colesevelam hydrochloride in oral suspension
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Time frame: Baseline to Month 6 post-dose
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Time frame: Baseline to Month 12 post-dose
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.
Time frame: Baseline to Month 12 post-dose
Number of Participants Achieving a Response to Therapy to Month 12
Participants achieving a response to therapy, ie, glycemic control, were assessed with the last observation after 1 month before any rescue therapy carried forward at Month 6 and Month 12. Response to therapy was defined as HbA1c \<7.0% or \<6.5%, reduction in HbA1c ≥0.7% or ≥0.5% from baseline, and/or reduction in FPG ≥30 mg/dL from baseline.
Time frame: Baseline to Month 12 post-dose
Percent Change From Baseline to Month 6 in Plasma Lipids
The percent change in plasma lipids from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Time frame: Baseline to Month 6 post-dose
Percent Change From Baseline to Month 6 in Triglycerides
The percent change in triglycerides from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
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Unnamed facility
Los Angeles, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Hartford, Connecticut, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
...and 14 more locations
Time frame: Baseline to Month 6 post-dose
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Rescue criteria was defined as HbA1c levels ≥8.5% after 3 months or ≥7.5% after 6 months (≥173 days) (confirmed persistent hyperglycemia) of study medication treatment, as measured by the central laboratory.
Time frame: Baseline to Month 12 post-dose