Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

Sponsor
AstraZeneca
Study ID
NCT02471404
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg, orally Green, plain, diamond-shaped, film-coated tablet
  • Saxagliptin — DRUG
    5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
  • Glimepiride — DRUG
    1, 2, or 4 mg, orally Opaque gray capsule
  • Placebo for dapagliflozin — DRUG
    Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
  • Placebo for saxagliptin — DRUG
    Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
  • Placebo for glimepiride — DRUG
    Does not contain active ingredient, orally. Opaque gray capsule

Study Details

This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.

Key Dates

Start date
Sep 21, 2015
Status verified
Mar 2019
Primary completion
Mar 13, 2017
Completion
Mar 13, 2017

Study Design

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

Arms

  • Active Comparator: Dapagliflozin+metformin
    Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
  • Active Comparator: Dapagliflozin+saxagliptin+metformin
    Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
  • Active Comparator: Glimepiride+metformin
    Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin

Primary Outcome Measure

Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 [ Time Frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis ]

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