Clinical trial NCT01368081: Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2011-06-07
Enrollment: 1162
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Patients With Drug Related Adverse Events
timeFrame: After the first drug intake until 7 days after the last treatment administration, up to 383 days
Secondary outcomes:
measure: Change From Baseline in HbA1c
timeFrame: Baseline and 52 weeks
Other outcomes:
measure: Confirmed Hypoglycaemic Adverse Events
timeFrame: After the first drug intake until 7 days after the last treatment administration, up to 383 days
Locations:
city: Adachi-ku, Tokyo
country: Japan
facility: 1245.52.023 Boehringer Ingelheim Investigational Site
city: Aki-gun, Hiroshima
country: Japan
facility: 1245.52.048 Boehringer Ingelheim Investigational Site
city: Annaka, Gunma
country: Japan
facility: 1245.52.012 Boehringer Ingelheim Investigational Site
city: Atami, Shizuoka
country: Japan
facility: 1245.52.087 Boehringer Ingelheim Investigational Site
city: Beppu, Oita
country: Japan
facility: 1245.52.008 Boehringer Ingelheim Investigational Site
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1245.52.073 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.52.002 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.52.020 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.52.021 Boehringer Ingelheim Investigational Site
city: Fujisawa, Kanagawa
country: Japan
facility: 1245.52.031 Boehringer Ingelheim Investigational Site
city: Fukuoka, Fukuoka
country: Japan
facility: 1245.52.077 Boehringer Ingelheim Investigational Site
city: Hadano, Kanagawa
country: Japan
facility: 1245.52.086 Boehringer Ingelheim Investigational Site
city: Hamamatsu, Shizuoka
country: Japan
facility: 1245.52.037 Boehringer Ingelheim Investigational Site
city: Himeji, Hyogo
country: Japan
facility: 1245.52.046 Boehringer Ingelheim Investigational Site
city: Hiroshima, Hiroshima
country: Japan
facility: 1245.52.047 Boehringer Ingelheim Investigational Site
city: Imabari, Ehime
country: Japan
facility: 1245.52.051 Boehringer Ingelheim Investigational Site
city: Iruma,Saitama
country: Japan
facility: 1245.52.016 Boehringer Ingelheim Investigational Site
city: Isehara, Kanagawa
country: Japan
facility: 1245.52.033 Boehringer Ingelheim Investigational Site
city: Isesaki, Gunma
country: Japan
facility: 1245.52.011 Boehringer Ingelheim Investigational Site
city: Izumisano,Osaka
country: Japan
facility: 1245.52.045 Boehringer Ingelheim Investigational Site
city: Kamakura, Kanagawa
country: Japan
facility: 1245.52.088 Boehringer Ingelheim Investigational Site
city: Kamakura,Kanagawa
country: Japan
facility: 1245.52.072 Boehringer Ingelheim Investigational Site
city: Kanazawa, Ishikawa
country: Japan
facility: 1245.52.034 Boehringer Ingelheim Investigational Site
city: Kanoya, Kagoshima
country: Japan
facility: 1245.52.058 Boehringer Ingelheim Investigational Site
city: Kashiwa, Chiba
country: Japan
facility: 1245.52.019 Boehringer Ingelheim Investigational Site
city: Kasugai, Aichi
country: Japan
facility: 1245.52.039 Boehringer Ingelheim Investigational Site
city: Kawasaki, Kanagawa
country: Japan
facility: 1245.52.027 Boehringer Ingelheim Investigational Site
city: Kita-adachi-gun, Saitama
country: Japan
facility: 1245.52.018 Boehringer Ingelheim Investigational Site
city: Kita-ku, Tokyo
country: Japan
facility: 1245.52.022 Boehringer Ingelheim Investigational Site
city: Kitakyushu, Fukuoka
country: Japan
facility: 1245.52.052 Boehringer Ingelheim Investigational Site
city: Kobe, Hyogo
country: Japan
facility: 1245.52.076 Boehringer Ingelheim Investigational Site
city: Kodaira, Tokyo
country: Japan
facility: 1245.52.026 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 1245.52.069 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 1245.52.071 Boehringer Ingelheim Investigational Site
city: Koshigaya, Saitama
country: Japan
facility: 1245.52.014 Boehringer Ingelheim Investigational Site
city: Kuki, Saitama
country: Japan
facility: 1245.52.074 Boehringer Ingelheim Investigational Site
city: Kumamoto, Kumamoto
country: Japan
facility: 1245.52.055 Boehringer Ingelheim Investigational Site
city: Kure, Hiroshima
country: Japan
facility: 1245.52.049 Boehringer Ingelheim Investigational Site
city: Kyoto, Kyoto
country: Japan
facility: 1245.52.040 Boehringer Ingelheim Investigational Site
city: Maebashi, Gunma
country: Japan
facility: 1245.52.010 Boehringer Ingelheim Investigational Site
city: Maebashi, Gunma
country: Japan
facility: 1245.52.080 Boehringer Ingelheim Investigational Site
city: Matsuyama, Ehime
country: Japan
facility: 1245.52.050 Boehringer Ingelheim Investigational Site
city: Meguro-ku, Tokyo
country: Japan
facility: 1245.52.075 Boehringer Ingelheim Investigational Site
city: Miyazaki, Miyazaki
country: Japan
facility: 1245.52.056 Boehringer Ingelheim Investigational Site
city: Miyazaki, Miyazaki
country: Japan
facility: 1245.52.057 Boehringer Ingelheim Investigational Site
city: Morioka, Iwate
country: Japan
facility: 1245.52.079 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1245.52.003 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1245.52.004 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1245.52.005 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1245.52.038 Boehringer Ingelheim Investigational Site
city: Naha, Okinawa
country: Japan
facility: 1245.52.059 Boehringer Ingelheim Investigational Site
city: Naha, Okinawa
country: Japan
facility: 1245.52.066 Boehringer Ingelheim Investigational Site
city: Nanjyo, Okinawa
country: Japan
facility: 1245.52.065 Boehringer Ingelheim Investigational Site
city: Oita, Oita
country: Japan
facility: 1245.52.007 Boehringer Ingelheim Investigational Site
city: Okawa, Fukuoka
country: Japan
facility: 1245.52.053 Boehringer Ingelheim Investigational Site
city: Okinawa, Okinawa
country: Japan
facility: 1245.52.068 Boehringer Ingelheim Investigational Site
city: Osaka,Osaka
country: Japan
facility: 1245.52.042 Boehringer Ingelheim Investigational Site
city: Osaki, Miyagi
country: Japan
facility: 1245.52.089 Boehringer Ingelheim Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: 1245.52.024 Boehringer Ingelheim Investigational Site
city: Saga, Saga
country: Japan
facility: 1245.52.054 Boehringer Ingelheim Investigational Site
city: Sagamihara, Kanagawa
country: Japan
facility: 1245.52.032 Boehringer Ingelheim Investigational Site
city: Sagamihara, Kanagawa
country: Japan
facility: 1245.52.085 Boehringer Ingelheim Investigational Site
city: Saitama, Saitama
country: Japan
facility: 1245.52.013 Boehringer Ingelheim Investigational Site
city: Sakado, Saitama
country: Japan
facility: 1245.52.015 Boehringer Ingelheim Investigational Site
city: Sakai, Osaka
country: Japan
facility: 1245.52.044 Boehringer Ingelheim Investigational Site
city: Saku, Nagano
country: Japan
facility: 1245.52.035 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1245.52.009 Boehringer Ingelheim Investigational Site
city: Setagaya-ku, Tokyo
country: Japan
facility: 1245.52.025 Boehringer Ingelheim Investigational Site
city: Shimajiri-gun, Okinawa
country: Japan
facility: 1245.52.063 Boehringer Ingelheim Investigational Site
city: Shimajiri-gun, Okinawa
country: Japan
facility: 1245.52.064 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku. Tokyo
country: Japan
facility: 1245.52.001 Boehringer Ingelheim Investigational Site
city: Shizuoka, Shizuoka
country: Japan
facility: 1245.52.036 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1245.52.006 Boehringer Ingelheim Investigational Site
city: Takatsuki, Osaka
country: Japan
facility: 1245.52.043 Boehringer Ingelheim Investigational Site
city: Tokorozawa, Saitama
country: Japan
facility: 1245.52.017 Boehringer Ingelheim Investigational Site
city: Tokorozawa, Saitama
country: Japan
facility: 1245.52.070 Boehringer Ingelheim Investigational Site
city: Tomigusuku, Okinawa
country: Japan
facility: 1245.52.061 Boehringer Ingelheim Investigational Site
city: Tomigusuku, Okinawa
country: Japan
facility: 1245.52.062 Boehringer Ingelheim Investigational Site
city: Uji, Kyoto
country: Japan
facility: 1245.52.041 Boehringer Ingelheim Investigational Site
city: Uruma, Okinawa
country: Japan
facility: 1245.52.067 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1245.52.028 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1245.52.029 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1245.52.030 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1245.52.081 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1245.52.082 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1245.52.083 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1245.52.084 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
citation: Araki E, Tanizawa Y, Tanaka Y, Taniguchi A, Koiwai K, Kim G, Salsali A, Woerle HJ, Broedl UC. Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):665-74. doi: 10.1111/dom.12464. Epub 2015 Apr 15.