Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus

Sponsor
Boehringer Ingelheim
Study ID
NCT02453555
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This trial will compare the use of fixed dose combination of empagliflozin and linagliptin to linagliptin alone in patient with type 2 diabetes mellitus

Key Dates

Start date
May 14, 2015
Status verified
Sep 2018
Primary completion
Aug 26, 2016
Completion
Mar 27, 2017

Study Design

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

Arms

  • Active Comparator: Linagliptin
    patient to receive 5 mg linagliptin once daily
  • Experimental: Empagliflozin + linagliptin low dose
    patient to receive one tablet once daily
  • Experimental: Empagliflozin + linagliptin high dose
    patient to receive one tablet once daily
  • Placebo Comparator: Linagliptin placebo
  • Placebo Comparator: Empagliflozin + linagliptin high dose placebo
  • Placebo Comparator: Empagliflozin + linagliptin low dose placebo

Primary Outcome Measure

Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline) [ Time Frame: Baseline and 24 week ]

Related Studies