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NCT01368081 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01368081
Other study ID # 1245.52
Secondary ID
Status Completed
Phase Phase 3
First received May 19, 2011
Last updated May 16, 2014
Start date May 2011
Est. completion date April 2013

Study information
Verified date May 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1162
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin
Metformin tablets 500-2250 mg a day (twice or three times per day)
• BI 10773
BI 10773 low dose tablet once daily
• Placebo (low dose)
Placebo tablets once daily
• BI 10773
BI 10773 high dose tablet once daily
• Placebo (high dose)
Placebo tablets once daily

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

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Other Confirmed Hypoglycaemic Adverse Events 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 No
Primary Number of Patients With Drug Related Adverse Events 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 No
Secondary Change From Baseline in HbA1c Change from baseline in HbA1c after 52 weeks of treatment Baseline and 52 weeks No
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