Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus

Sponsor
Boehringer Ingelheim
Study ID
NCT02589639
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Empagliflozin — DRUG
  • Placebo — DRUG
  • Placebo — DRUG
    For blinding purposes

Study Details

This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control

Key Dates

Start date
Oct 28, 2015
Status verified
Dec 2018
Primary completion
Apr 18, 2017
Completion
Jan 5, 2018

Study Design

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

Arms

  • Experimental: empagliflozin 10 mg
  • Experimental: empagliflozin 25 mg
  • Placebo Comparator: placebo

Primary Outcome Measure

Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment. [ Time Frame: Baseline and 16 weeks ]

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