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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193218
• Other study ID #: 1245.38
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2010
• Last updated: May 16, 2014
• Start date: September 2010
• Est. completion date: June 2012

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo (low dose)
Placebo tablets once a day
• Placebo (low dose)
Placebo tablets once a day
• Placebo (mid dose)
Placebo tablets once a day
• Placebo (high dose)
Placebo tablets once a day
• BI 10773
BI 10773 tablets low dose once a day
• Placebo (mid dose)
Placebo tablets once a day
• Placebo (high dose)
Placebo tablets once a day
• Placebo (high dose)
Placebo tablets once a day
• BI 10773
BI 10773 tablets mid-high dose once a day
• BI 10773
BI 10773 tablets high dose once a day
• Placebo (mid dose)
Placebo tablets once a day
• Placebo (high dose)
Placebo tablets once a day
• Placebo (low dose)
Placebo tablets once a day
• Placebo (low dose)
Placebo tablets once a day
• BI 10773
BI 10773 tablets mid-low dose once a day
• Placebo (mid dose)
Placebo tablets once a day

Locations

Country	Name	City	State
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	1245.38.006 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1245.38.007 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1245.38.008 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1245.38.009 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1245.38.012 Boehringer Ingelheim Investigational Site	Sasima-gun, Ibaraki
Japan	1245.38.015 Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo
Japan	1245.38.018 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	1245.38.026 Boehringer Ingelheim Investigational Site	Urasoe, Okinawa
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

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	between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days	No
Primary	Change From Baseline in HbA1c After 12 Weeks of Treatment.	The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.	baseline and 12 weeks	No
Secondary	Occurrence of Treat to Target Efficacy Response	Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment	baseline and 12 weeks	No
Secondary	Change From Baseline in FPG	Change from baseline in FPG after 12 weeks of treatment	baseline and 12 weeks	No

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