Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes

Sponsor
Boehringer Ingelheim
Study ID
NCT01984606
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin once daily
  • Placebo — DRUG
    Placebo matching empagliflozin
  • Sitagliptin — DRUG
    Sitagliptin once daily
  • Placebo — DRUG
    Placebo matching sitagliptin

Study Details

The purpose of this study is to assess safety and efficacy of empagliflozin compared to sitagliptin in patients with type 2 diabetes mellitus who are treatment-naive or on treatment with metformin and have insufficient glycaemic control. The study will assess non-inferiority of empagliflozin to sitagliptin with regards to HbA1c.

Key Dates

Start date
Jan 31, 2015
Status verified
Oct 2014
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

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

Arms

  • Experimental: Empagliflozin
    Empagliflozin once daily
  • Active Comparator: Sitagliptin
    Sitagliptin once daily

Primary Outcome Measure

The change from baseline in HbA1c after 52 weeks of treatment. [ Time Frame: Baseline and week 52 ]

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