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4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

NCT00885118 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-11-25

Study results available
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Summary

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo (middle dose)

Placebo tablets once a day

DRUG

Placebo

Placebo tablets once a day

DRUG

BI 10773

BI 10773 middle dose tablets once a day

DRUG

BI 10773

BI 10773 high dose tablets once a day

DRUG

BI 10773

BI 10773 middle dose tablets once a day

DRUG

Placebo (high dose)

Placebo tablets once a day

DRUG

BI 10773

BI 10773 low dose tablets once a day

DRUG

Placebo (low dose)

Placebo tablets once a day

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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-10-31

Countries

  • Japan

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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 NCT00885118 on ClinicalTrials.gov