Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01193218
Last Updated: 2014-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
547 participants
INTERVENTIONAL
2010-09-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 10773 low dose QD
BI 10773 tablets low dose 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
BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
Placebo (high 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
BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
BI 10773
BI 10773 tablets mid-high dose once a day
Placebo (high dose)
Placebo tablets once a day
Placebo (low dose)
Placebo tablets once a day
Placebo (mid dose)
Placebo tablets once a day
BI 10773 high dose QD
BI 10773 tablets high dose once a day
Placebo (low dose)
Placebo tablets once a day
Placebo (mid dose)
Placebo tablets once a day
BI 10773
BI 10773 tablets high dose once a day
Placebo
Placebo tablets once a day
Placebo (low dose)
Placebo tablets once a day
Placebo (high dose)
Placebo tablets once a day
Placebo (mid dose)
Placebo tablets once a day
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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, , Japan
Countries
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References
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Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
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.
Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.
Other Identifiers
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1245.38
Identifier Type: -
Identifier Source: org_study_id
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