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

NCT01368081 | Completed Phase 3 Results

• 1 other identifier: 1245.52
• Study Type: interventional
• Target: 1,162
• Locations: 1 country
• Sites: 87

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change From Baseline in HbA1c

  Baseline and 52 weeks

Other Outcomes (1)

• Confirmed Hypoglycaemic Adverse Events

  After the first drug intake until 7 days after the last treatment administration, up to 383 days

Study Arms (3)

BI 10773 low dose

EXPERIMENTAL

BI 10773 low dose tablet once daily

Drug: BI 10773; Drug: Placebo (high dose)

BI 10773 high dose

EXPERIMENTAL

BI 10773 high dose tablet once daily

Drug: Placebo (low dose); Drug: BI 10773

Metformin

ACTIVE COMPARATOR

Metformin tablets 500-2250 mg a day (twice or three times per day)

Drug: Metformin

Interventions

Metformin DRUG

Metformin tablets 500-2250 mg a day (twice or three times per day)

Metformin

BI 10773 DRUG

BI 10773 low dose tablet once daily

BI 10773 low dose

Placebo (low dose) DRUG

Placebo tablets once daily

BI 10773 high dose

Placebo (high dose) DRUG

Placebo tablets once daily

BI 10773 low dose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (87)

1245.52.023 Boehringer Ingelheim Investigational Site

Adachi-ku, Tokyo, Japan

Location

1245.52.048 Boehringer Ingelheim Investigational Site

Aki-gun, Hiroshima, Japan

Location

1245.52.012 Boehringer Ingelheim Investigational Site

Annaka, Gunma, Japan

Location

1245.52.087 Boehringer Ingelheim Investigational Site

Atami, Shizuoka, Japan

Location

1245.52.008 Boehringer Ingelheim Investigational Site

Beppu, Oita, Japan

Location

1245.52.073 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

1245.52.002 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1245.52.020 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1245.52.021 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1245.52.031 Boehringer Ingelheim Investigational Site

Fujisawa, Kanagawa, Japan

Location

1245.52.077 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

1245.52.086 Boehringer Ingelheim Investigational Site

Hadano, Kanagawa, Japan

Location

1245.52.037 Boehringer Ingelheim Investigational Site

Hamamatsu, Shizuoka, Japan

Location

1245.52.046 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, Japan

Location

1245.52.047 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, Japan

Location

1245.52.051 Boehringer Ingelheim Investigational Site

Imabari, Ehime, Japan

Location

1245.52.016 Boehringer Ingelheim Investigational Site

Iruma,Saitama, Japan

Location

1245.52.033 Boehringer Ingelheim Investigational Site

Isehara, Kanagawa, Japan

Location

1245.52.011 Boehringer Ingelheim Investigational Site

Isesaki, Gunma, Japan

Location

1245.52.045 Boehringer Ingelheim Investigational Site

Izumisano,Osaka, Japan

Location

1245.52.088 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, Japan

Location

1245.52.072 Boehringer Ingelheim Investigational Site

Kamakura,Kanagawa, Japan

Location

1245.52.034 Boehringer Ingelheim Investigational Site

Kanazawa, Ishikawa, Japan

Location

1245.52.058 Boehringer Ingelheim Investigational Site

Kanoya, Kagoshima, Japan

Location

1245.52.019 Boehringer Ingelheim Investigational Site

Kashiwa, Chiba, Japan

Location

1245.52.039 Boehringer Ingelheim Investigational Site

Kasugai, Aichi, Japan

Location

1245.52.027 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, Japan

Location

1245.52.018 Boehringer Ingelheim Investigational Site

Kita-adachi-gun, Saitama, Japan

Location

1245.52.022 Boehringer Ingelheim Investigational Site

Kita-ku, Tokyo, Japan

Location

1245.52.052 Boehringer Ingelheim Investigational Site

Kitakyushu, Fukuoka, Japan

Location

1245.52.076 Boehringer Ingelheim Investigational Site

Kobe, Hyogo, Japan

Location

1245.52.026 Boehringer Ingelheim Investigational Site

Kodaira, Tokyo, Japan

Location

1245.52.069 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

1245.52.071 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

1245.52.014 Boehringer Ingelheim Investigational Site

Koshigaya, Saitama, Japan

Location

1245.52.074 Boehringer Ingelheim Investigational Site

Kuki, Saitama, Japan

Location

1245.52.055 Boehringer Ingelheim Investigational Site

Kumamoto, Kumamoto, Japan

Location

1245.52.049 Boehringer Ingelheim Investigational Site

Kure, Hiroshima, Japan

Location

1245.52.040 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

1245.52.010 Boehringer Ingelheim Investigational Site

Maebashi, Gunma, Japan

Location

1245.52.080 Boehringer Ingelheim Investigational Site

Maebashi, Gunma, Japan

Location

1245.52.050 Boehringer Ingelheim Investigational Site

Matsuyama, Ehime, Japan

Location

1245.52.075 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, Japan

Location

1245.52.056 Boehringer Ingelheim Investigational Site

Miyazaki, Miyazaki, Japan

Location

1245.52.057 Boehringer Ingelheim Investigational Site

Miyazaki, Miyazaki, Japan

Location

1245.52.079 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

1245.52.003 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1245.52.004 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1245.52.005 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1245.52.038 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1245.52.059 Boehringer Ingelheim Investigational Site

Naha, Okinawa, Japan

Location

1245.52.066 Boehringer Ingelheim Investigational Site

Naha, Okinawa, Japan

Location

1245.52.065 Boehringer Ingelheim Investigational Site

Nanjyo, Okinawa, Japan

Location

1245.52.007 Boehringer Ingelheim Investigational Site

Oita, Oita, Japan

Location

1245.52.053 Boehringer Ingelheim Investigational Site

Okawa, Fukuoka, Japan

Location

1245.52.068 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, Japan

Location

1245.52.042 Boehringer Ingelheim Investigational Site

Osaka,Osaka, Japan

Location

1245.52.089 Boehringer Ingelheim Investigational Site

Osaki, Miyagi, Japan

Location

1245.52.024 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, Japan

Location

1245.52.054 Boehringer Ingelheim Investigational Site

Saga, Saga, Japan

Location

1245.52.032 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, Japan

Location

1245.52.085 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, Japan

Location

1245.52.013 Boehringer Ingelheim Investigational Site

Saitama, Saitama, Japan

Location

1245.52.015 Boehringer Ingelheim Investigational Site

Sakado, Saitama, Japan

Location

1245.52.044 Boehringer Ingelheim Investigational Site

Sakai, Osaka, Japan

Location

1245.52.035 Boehringer Ingelheim Investigational Site

Saku, Nagano, Japan

Location

1245.52.009 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1245.52.025 Boehringer Ingelheim Investigational Site

Setagaya-ku, Tokyo, Japan

Location

1245.52.063 Boehringer Ingelheim Investigational Site

Shimajiri-gun, Okinawa, Japan

Location

1245.52.064 Boehringer Ingelheim Investigational Site

Shimajiri-gun, Okinawa, Japan

Location

1245.52.001 Boehringer Ingelheim Investigational Site

Shinjuku-ku. Tokyo, Japan

Location

1245.52.036 Boehringer Ingelheim Investigational Site

Shizuoka, Shizuoka, Japan

Location

1245.52.006 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1245.52.043 Boehringer Ingelheim Investigational Site

Takatsuki, Osaka, Japan

Location

1245.52.017 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, Japan

Location

1245.52.070 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, Japan

Location

1245.52.061 Boehringer Ingelheim Investigational Site

Tomigusuku, Okinawa, Japan

Location

1245.52.062 Boehringer Ingelheim Investigational Site

Tomigusuku, Okinawa, Japan

Location

1245.52.041 Boehringer Ingelheim Investigational Site

Uji, Kyoto, Japan

Location

1245.52.067 Boehringer Ingelheim Investigational Site

Uruma, Okinawa, Japan

Location

1245.52.028 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

1245.52.029 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

1245.52.030 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

1245.52.081 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

1245.52.082 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

1245.52.083 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

1245.52.084 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

Related Publications (2)

• 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.

  PMID: 28753486 DERIVED

• 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.

  PMID: 25772548 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: June 7, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-05

Locations

JP (87)