NCT01258075

Colesevelam for Children With Type 2 Diabetes

Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 \[HbA1c\]).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	High-dose colesevelam	3.75 grams colesevelam hydrochloride in oral suspension
DRUG	Low-dose colesevelam	0.625 grams colesevelam hydrochloride in oral suspension

Timeline

• Start date: 2011-02-24
• Primary completion: 2019-11-01
• Completion: 2020-04-21
• First posted: 2010-12-10
• Last updated: 2021-05-13
• Results posted: 2020-12-22

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study