Safety and Efficacy of Dapagliflozin in Asian T2DM subjects with Inadequate glycemic control on Metformin/Saxagliptin
Study identifier:D1683C00008
ClinicalTrials.gov identifier:NCT03608358
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Asian Subjects with T2DM and Inadequate Glycemic Control on Metformin and Saxagliptin (DS Navigation)
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin 10 mg, Dapagliflozin 5 mg, Dapagliflozin 10 mg placebo to match, Dapagliflozin 5 mg placebo to match, Saxagliptin 5 mg, Metformin
Sex
All
Actual Enrollment
41
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 27 Feb 2019
Primary Completion Date: 04 Aug 2020
Study Completion Date: 04 Aug 2020
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 May 2022 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dapagliflozin 10 mg Dapagliflozin 10 mg and dapagliflozin 5 mg placebo to match added to saxagliptin 5 mg and metformin | Drug: Dapagliflozin 10 mg 10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period Drug: Dapagliflozin 5 mg placebo to match 5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period Drug: Saxagliptin 5 mg 5 mg, oral tablet, once daily for 24 weeks of double-blinded treatment period, and for 16 weeks of open-label treatment period in Stratum A or 8 weeks of open-label treatment period in Stratum B Drug: Metformin Stable dose of metformin immediate release/extended release (≥ 1500 mg/day or at a maximal tolerated dose) throughout the whole study period |
| Experimental: Dapagliflozin 5 mg Dapagliflozin 5 mg and dapagliflozin 10 mg placebo to match added to saxagliptin 5 mg and metformin | Drug: Dapagliflozin 5 mg 5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period Drug: Dapagliflozin 10 mg placebo to match 10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period Drug: Saxagliptin 5 mg 5 mg, oral tablet, once daily for 24 weeks of double-blinded treatment period, and for 16 weeks of open-label treatment period in Stratum A or 8 weeks of open-label treatment period in Stratum B Drug: Metformin Stable dose of metformin immediate release/extended release (≥ 1500 mg/day or at a maximal tolerated dose) throughout the whole study period |
| Placebo Comparator: Placebo Dapagliflozin 5 mg placebo to match and dapagliflozin 10 mg placebo to match added to saxagliptin 5 mg and metformin | Drug: Dapagliflozin 10 mg placebo to match 10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period Drug: Dapagliflozin 5 mg placebo to match 5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period Drug: Saxagliptin 5 mg 5 mg, oral tablet, once daily for 24 weeks of double-blinded treatment period, and for 16 weeks of open-label treatment period in Stratum A or 8 weeks of open-label treatment period in Stratum B Drug: Metformin Stable dose of metformin immediate release/extended release (≥ 1500 mg/day or at a maximal tolerated dose) throughout the whole study period |
Contacts
Investigators
Principal Investigator
Linong Ji
People's Hospital of Peking Universty
