Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus

Sponsor
Boehringer Ingelheim
Study ID
NCT02702011
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.

Key Dates

Start date
Mar 20, 2016
Status verified
Sep 2017
Primary completion
Sep 5, 2016
Completion
Oct 3, 2016

Study Design

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

Arms

  • Experimental: empagliflozin low dose
  • Experimental: empagliflozin medium dose
  • Experimental: empagliflozin high dose
  • Placebo Comparator: placebo

Primary Outcome Measure

Change From Baseline in 24 Hour UGE on Day 7 [ Time Frame: Baseline and 7 days ]

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