Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin

Sponsor
AstraZeneca
Study ID
NCT03608358
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 mg — DRUG
    10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period
  • Dapagliflozin 5 mg — DRUG
    5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period
  • Dapagliflozin 10 mg placebo to match — DRUG
    10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period
  • Dapagliflozin 5 mg placebo to match — DRUG
    5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period
  • Saxagliptin 5 mg — DRUG
    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
  • Metformin — DRUG
    Stable dose of metformin immediate release/extended release (≥ 1500 mg/day or at a maximal tolerated dose) throughout the whole study period

Study Details

This is a 24-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, phase 3 study designed to evaluate if the safety and efficacy of dapagliflozin 5 mg or 10 mg added to saxagliptin 5 mg plus metformin is superior to placebo added to saxagliptin 5 mg plus metformin in reducing hemoglobin A1c (HbA1c).

Key Dates

Start date
Feb 27, 2019
Status verified
May 2022
Primary completion
Aug 4, 2020
Completion
Aug 4, 2020

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin 10 mg
    Dapagliflozin 10 mg and dapagliflozin 5 mg placebo to match added to saxagliptin 5 mg and metformin
  • Experimental: Dapagliflozin 5 mg
    Dapagliflozin 5 mg and dapagliflozin 10 mg placebo to match added to saxagliptin 5 mg and metformin
  • Placebo Comparator: Placebo
    Dapagliflozin 5 mg placebo to match and dapagliflozin 10 mg placebo to match added to saxagliptin 5 mg and metformin

Primary Outcome Measure

Mean change from baseline in HbA1c at Week 24 [ Time Frame: Baseline to Week 24 ]

Related Studies