Completed PHASE2 INTERVENTIONAL 5-arm NCT01193218

Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)

Sponsor: Boehringer Ingelheim

Conditions Diabetes Mellitus, Type 2

Interventions BI 10773 Placebo (high dose) Placebo (low dose) Placebo (mid dose)

Updated 5 times since 2017 Last updated: May 16, 2014 Started: Sep 30, 2010 Primary completion: Jun 30, 2012 Completion: Jun 30, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Diabetes Mellitus, Type 2, this trial is completed. The trial is conducted by Boehringer Ingelheim and has accumulated 5 data snapshots since 2010. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Jan 2017 — Jun 2018 [monthly]

Completed PHASE2

First recorded

Sep 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Boehringer Ingelheim
Eli Lilly and Company

Data source: Boehringer Ingelheim

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Chiyoda-ku, Tokyo, Japan , Chuo-ku, Tokyo, Japan , Hachioji, Tokyo, Japan , Hanamaki, Iwate, Japan , Kamakura, Kanagawa, Japan , Kanazawa, Ishikawa, Japan , Kashiwa, Chiba, Japan , Katsushika-ku, Tokyo, Japan , Kyoto, Kyoto, Japan , Matsuyama, Ehime, Japan and 14 more locations