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

NCT01947855 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-12-24

Study results available
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Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Placebo tablet matching Empagliflozin low dose

DRUG

Empagliflozin

Empagliflozin low dose

DRUG

Placebo

Placebo tablet matching Empagliflozin high dose

DRUG

Placebo

Placebo tablet matching Empagliflozin low dose

DRUG

Empagliflozin

Empagliflozin high dose tablet once daily

DRUG

Placebo

Placebo tablet matching Empagliflozin high dose

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01947855 on ClinicalTrials.gov