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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 |
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Investigator: T Barrett t.g.barrett@bham.ac.uk Sponsor: Astra Zeneca |
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Summary: The purpose of this research study is to evaluate the effectiveness and safety of dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18 years old and are currently taking metformin, insulin, or both medicines. |
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DINAMO: A Double-blind, Randomised, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Empagliflozin and Linagliptin Over 26 Weeks, With a Double-blind Active Treatment Safety Extension Period up to 52 Weeks, in Children and Adolescents With Type 2 Diabetes Mellitus |
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Investigator: Christina Wei, Christina.wei@nhs.net Sponsor: Boehringer Ingelheim |
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Summary: The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs. |
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Start Date: 20/03/2018 |
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End Date: 31/01/2022 |
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Further Information: https://clinicaltrials.gov/ct2/show/NCT03429543?term=DINAMO&rank=2 |