Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

May 16, 2014 updated by: Boehringer Ingelheim

A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Adachi-ku, Tokyo, Japan
        • 1245.52.023 Boehringer Ingelheim Investigational Site
      • Aki-gun, Hiroshima, Japan
        • 1245.52.048 Boehringer Ingelheim Investigational Site
      • Annaka, Gunma, Japan
        • 1245.52.012 Boehringer Ingelheim Investigational Site
      • Atami, Shizuoka, Japan
        • 1245.52.087 Boehringer Ingelheim Investigational Site
      • Beppu, Oita, Japan
        • 1245.52.008 Boehringer Ingelheim Investigational Site
      • Chiyoda-ku, Tokyo, Japan
        • 1245.52.073 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1245.52.002 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1245.52.020 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1245.52.021 Boehringer Ingelheim Investigational Site
      • Fujisawa, Kanagawa, Japan
        • 1245.52.031 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japan
        • 1245.52.077 Boehringer Ingelheim Investigational Site
      • Hadano, Kanagawa, Japan
        • 1245.52.086 Boehringer Ingelheim Investigational Site
      • Hamamatsu, Shizuoka, Japan
        • 1245.52.037 Boehringer Ingelheim Investigational Site
      • Himeji, Hyogo, Japan
        • 1245.52.046 Boehringer Ingelheim Investigational Site
      • Hiroshima, Hiroshima, Japan
        • 1245.52.047 Boehringer Ingelheim Investigational Site
      • Imabari, Ehime, Japan
        • 1245.52.051 Boehringer Ingelheim Investigational Site
      • Iruma,Saitama, Japan
        • 1245.52.016 Boehringer Ingelheim Investigational Site
      • Isehara, Kanagawa, Japan
        • 1245.52.033 Boehringer Ingelheim Investigational Site
      • Isesaki, Gunma, Japan
        • 1245.52.011 Boehringer Ingelheim Investigational Site
      • Izumisano,Osaka, Japan
        • 1245.52.045 Boehringer Ingelheim Investigational Site
      • Kamakura, Kanagawa, Japan
        • 1245.52.088 Boehringer Ingelheim Investigational Site
      • Kamakura,Kanagawa, Japan
        • 1245.52.072 Boehringer Ingelheim Investigational Site
      • Kanazawa, Ishikawa, Japan
        • 1245.52.034 Boehringer Ingelheim Investigational Site
      • Kanoya, Kagoshima, Japan
        • 1245.52.058 Boehringer Ingelheim Investigational Site
      • Kashiwa, Chiba, Japan
        • 1245.52.019 Boehringer Ingelheim Investigational Site
      • Kasugai, Aichi, Japan
        • 1245.52.039 Boehringer Ingelheim Investigational Site
      • Kawasaki, Kanagawa, Japan
        • 1245.52.027 Boehringer Ingelheim Investigational Site
      • Kita-adachi-gun, Saitama, Japan
        • 1245.52.018 Boehringer Ingelheim Investigational Site
      • Kita-ku, Tokyo, Japan
        • 1245.52.022 Boehringer Ingelheim Investigational Site
      • Kitakyushu, Fukuoka, Japan
        • 1245.52.052 Boehringer Ingelheim Investigational Site
      • Kobe, Hyogo, Japan
        • 1245.52.076 Boehringer Ingelheim Investigational Site
      • Kodaira, Tokyo, Japan
        • 1245.52.026 Boehringer Ingelheim Investigational Site
      • Koriyama, Fukushima, Japan
        • 1245.52.069 Boehringer Ingelheim Investigational Site
      • Koriyama, Fukushima, Japan
        • 1245.52.071 Boehringer Ingelheim Investigational Site
      • Koshigaya, Saitama, Japan
        • 1245.52.014 Boehringer Ingelheim Investigational Site
      • Kuki, Saitama, Japan
        • 1245.52.074 Boehringer Ingelheim Investigational Site
      • Kumamoto, Kumamoto, Japan
        • 1245.52.055 Boehringer Ingelheim Investigational Site
      • Kure, Hiroshima, Japan
        • 1245.52.049 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto, Japan
        • 1245.52.040 Boehringer Ingelheim Investigational Site
      • Maebashi, Gunma, Japan
        • 1245.52.010 Boehringer Ingelheim Investigational Site
      • Maebashi, Gunma, Japan
        • 1245.52.080 Boehringer Ingelheim Investigational Site
      • Matsuyama, Ehime, Japan
        • 1245.52.050 Boehringer Ingelheim Investigational Site
      • Meguro-ku, Tokyo, Japan
        • 1245.52.075 Boehringer Ingelheim Investigational Site
      • Miyazaki, Miyazaki, Japan
        • 1245.52.056 Boehringer Ingelheim Investigational Site
      • Miyazaki, Miyazaki, Japan
        • 1245.52.057 Boehringer Ingelheim Investigational Site
      • Morioka, Iwate, Japan
        • 1245.52.079 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1245.52.003 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1245.52.004 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1245.52.005 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1245.52.038 Boehringer Ingelheim Investigational Site
      • Naha, Okinawa, Japan
        • 1245.52.059 Boehringer Ingelheim Investigational Site
      • Naha, Okinawa, Japan
        • 1245.52.066 Boehringer Ingelheim Investigational Site
      • Nanjyo, Okinawa, Japan
        • 1245.52.065 Boehringer Ingelheim Investigational Site
      • Oita, Oita, Japan
        • 1245.52.007 Boehringer Ingelheim Investigational Site
      • Okawa, Fukuoka, Japan
        • 1245.52.053 Boehringer Ingelheim Investigational Site
      • Okinawa, Okinawa, Japan
        • 1245.52.068 Boehringer Ingelheim Investigational Site
      • Osaka,Osaka, Japan
        • 1245.52.042 Boehringer Ingelheim Investigational Site
      • Osaki, Miyagi, Japan
        • 1245.52.089 Boehringer Ingelheim Investigational Site
      • Ota-ku, Tokyo, Japan
        • 1245.52.024 Boehringer Ingelheim Investigational Site
      • Saga, Saga, Japan
        • 1245.52.054 Boehringer Ingelheim Investigational Site
      • Sagamihara, Kanagawa, Japan
        • 1245.52.032 Boehringer Ingelheim Investigational Site
      • Sagamihara, Kanagawa, Japan
        • 1245.52.085 Boehringer Ingelheim Investigational Site
      • Saitama, Saitama, Japan
        • 1245.52.013 Boehringer Ingelheim Investigational Site
      • Sakado, Saitama, Japan
        • 1245.52.015 Boehringer Ingelheim Investigational Site
      • Sakai, Osaka, Japan
        • 1245.52.044 Boehringer Ingelheim Investigational Site
      • Saku, Nagano, Japan
        • 1245.52.035 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1245.52.009 Boehringer Ingelheim Investigational Site
      • Setagaya-ku, Tokyo, Japan
        • 1245.52.025 Boehringer Ingelheim Investigational Site
      • Shimajiri-gun, Okinawa, Japan
        • 1245.52.063 Boehringer Ingelheim Investigational Site
      • Shimajiri-gun, Okinawa, Japan
        • 1245.52.064 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku. Tokyo, Japan
        • 1245.52.001 Boehringer Ingelheim Investigational Site
      • Shizuoka, Shizuoka, Japan
        • 1245.52.036 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japan
        • 1245.52.006 Boehringer Ingelheim Investigational Site
      • Takatsuki, Osaka, Japan
        • 1245.52.043 Boehringer Ingelheim Investigational Site
      • Tokorozawa, Saitama, Japan
        • 1245.52.017 Boehringer Ingelheim Investigational Site
      • Tokorozawa, Saitama, Japan
        • 1245.52.070 Boehringer Ingelheim Investigational Site
      • Tomigusuku, Okinawa, Japan
        • 1245.52.061 Boehringer Ingelheim Investigational Site
      • Tomigusuku, Okinawa, Japan
        • 1245.52.062 Boehringer Ingelheim Investigational Site
      • Uji, Kyoto, Japan
        • 1245.52.041 Boehringer Ingelheim Investigational Site
      • Uruma, Okinawa, Japan
        • 1245.52.067 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1245.52.028 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1245.52.029 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1245.52.030 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1245.52.081 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1245.52.082 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1245.52.083 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1245.52.084 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • .Diagnosis of type 2 diabetes mellitus prior to informed consent
  • Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
  • glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program)

Exclusion criteria:

  • Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
  • Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
  • Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BI 10773 low dose
BI 10773 low dose tablet once daily
Drug: BI 10773
BI 10773 low dose tablet once daily
Drug: BI 10773
BI 10773 high dose tablet once daily
Drug: Placebo (high dose)
Placebo tablets once daily
EXPERIMENTAL: BI 10773 high dose
BI 10773 high dose tablet once daily
Drug: BI 10773
BI 10773 low dose tablet once daily
Drug: BI 10773
BI 10773 high dose tablet once daily
Drug: Placebo (low dose)
Placebo tablets once daily
ACTIVE_COMPARATOR: Metformin
Metformin tablets 500-2250 mg a day (twice or three times per day)
Drug: Metformin
Metformin tablets 500-2250 mg a day (twice or three times per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Drug Related Adverse Events
Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
After the first drug intake until 7 days after the last treatment administration, up to 383 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c
Time Frame: Baseline and 52 weeks
Change from baseline in HbA1c after 52 weeks of treatment
Baseline and 52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed Hypoglycaemic Adverse Events
Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days
Number of patients with confirmed hypoglycaemic adverse events
After the first drug intake until 7 days after the last treatment administration, up to 383 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (ESTIMATE)

June 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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