Clinical trial NCT01193218: Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-09-01
Enrollment: 547
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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:

  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

Primary outcomes:
measure: Change From Baseline in HbA1c After 12 Weeks of Treatment.
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Occurrence of Treat to Target Efficacy Response
timeFrame: baseline and 12 weeks
measure: Change From Baseline in FPG
timeFrame: baseline and 12 weeks
Other outcomes:
measure: Confirmed Hypoglycaemic Adverse Events
timeFrame: 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
Locations:
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1245.38.016 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.38.001 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.38.003 Boehringer Ingelheim Investigational Site
city: Hachioji, Tokyo
country: Japan
facility: 1245.38.002 Boehringer Ingelheim Investigational Site
city: Hanamaki, Iwate
country: Japan
facility: 1245.38.010 Boehringer Ingelheim Investigational Site
city: Kamakura, Kanagawa
country: Japan
facility: 1245.38.005 Boehringer Ingelheim Investigational Site
city: Kanazawa, Ishikawa
country: Japan
facility: 1245.38.020 Boehringer Ingelheim Investigational Site
city: Kashiwa, Chiba
country: Japan
facility: 1245.38.013 Boehringer Ingelheim Investigational Site
city: Katsushika-ku, Tokyo
country: Japan
facility: 1245.38.019 Boehringer Ingelheim Investigational Site
city: Kyoto, Kyoto
country: Japan
facility: 1245.38.021 Boehringer Ingelheim Investigational Site
city: Matsuyama, Ehime
country: Japan
facility: 1245.38.024 Boehringer Ingelheim Investigational Site
city: Minato-ku, Tokyo
country: Japan
facility: 1245.38.004 Boehringer Ingelheim Investigational Site
city: Moriya, Ibaraki
country: Japan
facility: 1245.38.011 Boehringer Ingelheim Investigational Site
city: Naha, Okinawa
country: Japan
facility: 1245.38.030 Boehringer Ingelheim Investigational Site
city: Okawa, Fukuoka
country: Japan
facility: 1245.38.032 Boehringer Ingelheim Investigational Site
city: Okinawa, Okinawa
country: Japan
facility: 1245.38.031 Boehringer Ingelheim Investigational Site
city: Saga, Saga
country: Japan
facility: 1245.38.025 Boehringer Ingelheim Investigational Site
city: Saitama, Saitama
country: Japan
facility: 1245.38.014 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1245.38.006 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1245.38.007 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1245.38.008 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1245.38.009 Boehringer Ingelheim Investigational Site
city: Sasima-gun, Ibaraki
country: Japan
facility: 1245.38.012 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1245.38.015 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1245.38.018 Boehringer Ingelheim Investigational Site
city: Suginami-ku, Tokyo
country: Japan
facility: 1245.38.017 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1245.38.022 Boehringer Ingelheim Investigational Site
city: Ube, Yamaguchi
country: Japan
facility: 1245.38.023 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 1245.38.026 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 1245.38.027 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 1245.38.028 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 1245.38.029 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
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: 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.