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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01193218
First received: August 31, 2010
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo (low dose)
Drug: Placebo (mid dose)
Drug: Placebo (high dose)
Drug: BI 10773
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment. [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in FPG after 12 weeks of treatment [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 547
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose QD
BI 10773 tablets low dose once a day
Drug: Placebo (mid dose)
Placebo tablets once a day
Drug: Placebo (high dose)
Placebo tablets once a day
Drug: BI 10773
BI 10773 tablets low dose once a day
Experimental: BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
Drug: Placebo (high dose)
Placebo tablets once a day
Drug: Placebo (low dose)
Placebo tablets once a day
Drug: BI 10773
BI 10773 tablets mid-low dose once a day
Experimental: BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
Drug: BI 10773
BI 10773 tablets mid-high dose once a day
Drug: Placebo (high dose)
Placebo tablets once a day
Drug: Placebo (low dose)
Placebo tablets once a day
Drug: Placebo (mid dose)
Placebo tablets once a day
Experimental: BI 10773 high dose QD
BI 10773 tablets high dose once a day
Drug: Placebo (low dose)
Placebo tablets once a day
Drug: Placebo (mid dose)
Placebo tablets once a day
Drug: BI 10773
BI 10773 tablets high dose once a day
Placebo Comparator: Placebo
Placebo tablets once a day
Drug: Placebo (low dose)
Placebo tablets once a day
Drug: Placebo (high dose)
Placebo tablets once a day
Drug: Placebo (mid dose)
Placebo tablets once a day

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of type 2 diabetes mellitus prior to informed consent
  • Male and female patients on diet and exercise regimen who are:

    1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
    2. pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
  • HbA1c at Visit 1a:

    1. for patients who are drug naïve: HbA1c >=7.0 to =<10.0%
    2. for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%
  • HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)

Exclusion criteria:

  • Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
  • Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
  • Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
  • Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
  • Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
  • Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193218

Locations
Japan
1245.38.016 Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan
1245.38.001 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.38.003 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1245.38.002 Boehringer Ingelheim Investigational Site
Hachioji, Tokyo, Japan
1245.38.010 Boehringer Ingelheim Investigational Site
Hanamaki, Iwate, Japan
1245.38.005 Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan
1245.38.020 Boehringer Ingelheim Investigational Site
Kanazawa, Ishikawa, Japan
1245.38.013 Boehringer Ingelheim Investigational Site
Kashiwa, Chiba, Japan
1245.38.019 Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo, Japan
1245.38.021 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto, Japan
1245.38.024 Boehringer Ingelheim Investigational Site
Matsuyama, Ehime, Japan
1245.38.004 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
1245.38.011 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki, Japan
1245.38.030 Boehringer Ingelheim Investigational Site
Naha, Okinawa, Japan
1245.38.032 Boehringer Ingelheim Investigational Site
Okawa, Fukuoka, Japan
1245.38.031 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa, Japan
1245.38.025 Boehringer Ingelheim Investigational Site
Saga, Saga, Japan
1245.38.014 Boehringer Ingelheim Investigational Site
Saitama, Saitama, Japan
1245.38.008 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1245.38.006 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1245.38.009 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1245.38.007 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1245.38.012 Boehringer Ingelheim Investigational Site
Sasima-gun, Ibaraki, Japan
1245.38.018 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1245.38.015 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1245.38.017 Boehringer Ingelheim Investigational Site
Suginami-ku, Tokyo, Japan
1245.38.022 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1245.38.023 Boehringer Ingelheim Investigational Site
Ube, Yamaguchi, Japan
1245.38.027 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
1245.38.028 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
1245.38.029 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
1245.38.026 Boehringer Ingelheim Investigational Site
Urasoe, Okinawa, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01193218     History of Changes
Other Study ID Numbers: 1245.38
Study First Received: August 31, 2010
Last Updated: November 14, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014