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DHRHealth Institute for Research and Development

Clinical Trial

A 26-Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial with a 26-Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients with Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age

Study Status:

Closed for enrollment

Contact Information:

(956) 362-2396

Please contact us for more information or to learn if you are eligible to participate.

Study Purpose:

The primary objective of this study is to determine if there will be a greater mean reduction from baseline in HbA1c achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin 5 mg or saxagliptin 2.5 mg compared to placebo in pediatric T2DM subjects with HbA1c levels of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin.

Information: 

Principal Investigator
Marcel Twahirwa, MD
Co-PI
Luis Cantu Jr.
Sponsor
AstraZeneca
Type of Trial
Interventional
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