Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

Sponsor
Boehringer Ingelheim
Study ID
NCT01947855
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Placebo tablet matching Empagliflozin low dose
  • Empagliflozin — DRUG
    Empagliflozin low dose
  • Placebo — DRUG
    Placebo tablet matching Empagliflozin high dose
  • Placebo — DRUG
    Placebo tablet matching Empagliflozin low dose
  • Empagliflozin — DRUG
    Empagliflozin high dose tablet once daily
  • Placebo — DRUG
    Placebo tablet matching Empagliflozin high dose

Study Details

To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.

Key Dates

Start date
Sep 30, 2013
Status verified
Dec 2014
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

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

Arms

  • Experimental: Empagliflozin low dose
    Empagliflozin low dose tablet once daily
  • Experimental: Empagliflozin high dose
    Empagliflozin high dose tablet once daily
  • Placebo Comparator: Placebo
    Placebo tablet once daily

Primary Outcome Measure

Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment [ Time Frame: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28 ]

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