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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01368081
First received: May 19, 2011
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Metformin
Drug: BI 10773
Drug: Placebo (low dose)
Drug: Placebo (high dose)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Frequency of number of adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of hypoglycaemic events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of protocol specified significant adverse events (decreased renal function and hepatic injury) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of cardiovascular events (defined based on adjudication results of clinical event committee) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in vital signs (blood pressure and pulse rate) [ Time Frame: Baseline and 52 weeks at the maximum ] [ Designated as safety issue: Yes ]
  • Change from baseline in laboratory values [ Time Frame: Baseline and 52 weeks at the maximum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in HbA1c after 52 weeks of treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 1162
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose
BI 10773 low dose tablet once daily
 Drug: BI 10773
BI 10773 low 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: Placebo (low dose)
Placebo tablets once daily
Drug: BI 10773
BI 10773 high dose tablet 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)

  Eligibility

Ages Eligible for Study:   20 Years and older
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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368081

  Hide Study Locations
Locations
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
1245.52.071 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima, Japan
1245.52.069 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
1245.52.080 Boehringer Ingelheim Investigational Site
Maebashi, Gunma, Japan
1245.52.010 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
1245.52.004 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1245.52.003 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
1245.52.085 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa, Japan
1245.52.032 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
1245.52.070 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama, Japan
1245.52.017 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
1245.52.083 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
1245.52.084 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
1245.52.081 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
1245.52.082 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
1245.52.030 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01368081     History of Changes
Other Study ID Numbers: 1245.52
Study First Received: May 19, 2011
Last Updated: June 13, 2013
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
 Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013