Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT02489968
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg + linagliptin. All analyses will be carried out separately for these study parts. The objective of Part A is to investigate the efficacy, safety and tolerability of the fixed dose combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin 10 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM (Type 2 Diabetes Mellitus) who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placebo after 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safety and tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared with empagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 25 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mg plus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will be followed by a 28 week extension treatment period to evaluate further efficacy and safety up to 52 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 880
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description empagliflozin 10 mg + linagliptin 5 mg empagliflozin 10 mg + linagliptin 5 mg patient to receive a tablet containing low dose empagliflozin and linagliptin once daily empagliflozin 25 mg + linagliptin 5 mg empagliflozin 25 mg + linagliptin 5 mg patient to receive a tablet containing high dose empagliflozin and linagliptin once daily empagliflozin 10 mg empagliflozin 10 mg patient to receive a tablet containing low dose empagliflozin once daily empagliflozin 25 mg empagliflozin 25 mg patients to receive a tablet containing high dose empagliflozin once daily empagliflozin 10 mg Placebo patient to receive a tablet containing low dose empagliflozin once daily empagliflozin 25 mg Placebo patients to receive a tablet containing high dose empagliflozin once daily
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment Baseline and 24 week Change from baseline in HbA1c (%) after 24 weeks of treatment with double-blind trial medication. Change was calculated as: HbA1c value at 24-week - HbA1c value at baseline, for each patient. Baseline was defined as the last observation before the first intake of double-blind randomised trial medication. Statistical analysis presented is based on a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach. Full Analysis Set (Observed Cases) \[FAS (OC)\]: This analysis set consisted of all patients who were randomised and treated with at least 1 dose of trial drug during the double-blind part of the trial and who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the 24-week double-blind part of the trial. Observed cases analysis included only the available data that were observed while patients were on treatment, i.e., excluding the missing data.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (83)
Ebetsu Internal Medicine Clinic
🇯🇵Hokkaido, Ebetsu, Japan
Iida Medical Clinic
🇯🇵Hokkaido, Hakodate, Japan
Morinagaueno clinic, Kumamoto, Digestive Tract I.M.
🇯🇵Kumamoto, Kumamoto, Japan
AGE Makita Medical Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Kanda Clinic, Tokyo, I.M.
🇯🇵Tokyo, Japan
Shin Yukuhashi Hospital
🇯🇵Fukuoka, Yukuhashi, Japan
Odayaka Life Naika Clinic, Saitama, I.M.
🇯🇵Saitama, Koshigaya, Japan
Hamamatsu Rosai Hospital
🇯🇵Shizuoka, Hamamatsu, Japan
Nihonbashi Sakura Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Fukuwa Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Kikuchi Naika Clinic, Gunma, I.M.
🇯🇵Gunma, Maebashi, Japan
Manda Memorial Hospital
🇯🇵Hokkaido, Sapporo, Japan
Japan Community Health Care Organization Hokkaido Hospital
🇯🇵Hokkaido, Sapporo, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Kumamoto, Japan
Clinic Sugiyama, Yamagata, I.M.
🇯🇵Yamagata, Yamagata, Japan
Tokai Memorial Hospital
🇯🇵Aichi, Kasugai, Japan
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
🇯🇵Aichi, Nagoya, Japan
Kunisaki Makoto Clinic, Fukuoka, I.M./CV Med.
🇯🇵Fukuoka, Fukuoka, Japan
Fukuoka Shin Mizumaki Hospital
🇯🇵Fukuoka, Onga, Japan
Hashimoto I.M., Gifu, I.M.
🇯🇵Gifu, Gifu, Japan
Hasegawa Internal Medicine Clinic
🇯🇵Hokkaido, Chitose, Japan
Honda Hidehiko Clinic
🇯🇵Tokyo, Ota-ku, Japan
Murakami Memorial Hp., Ehime, I.M.
🇯🇵Ehime, Saijo, Japan
Hakodate Koseiin Hakodate Central General Hospital
🇯🇵Hokkaido, Hakodate, Japan
Uehara Clinic
🇯🇵Hokkaido, Sapporo, Japan
Namegata District General Hospital
🇯🇵Ibaraki, Namegata, Japan
Oikawa Clinic
🇯🇵Iwate, Morioka, Japan
Hirano Medical Clinic
🇯🇵Iwate, Morioka, Japan
Tokuyama Clinic
🇯🇵Chiba, Chiba, Japan
Tanaka Int. Clinic, Ehime, DIA Med.,CV Med.
🇯🇵Ehime, Niihama, Japan
Kurihara Clinic
🇯🇵Hokkaido, Sapporo, Japan
Sapporo Diabetes, Thyroid Clinic
🇯🇵Hokkaido, Sapporo, Japan
Hokuriku Hp., Ishikawa, I.M.
🇯🇵Ishikawa, Kanazawa, Japan
Ashiya Municipal Hospital
🇯🇵Hyogo, Ashiya, Japan
Itabashi DIA Med. and DERM Clinic, Ibaraki, I.M.
🇯🇵Ibaraki, Koga, Japan
Takai Naika Clinic
🇯🇵Kanagawa, Kamakura, Japan
Nagatsuta Family Clinic, Kanagawa, I.M.
🇯🇵Kanagawa, Yokohama, Japan
Jinnouchi Clinic Diabetes Care Center
🇯🇵Kumamoto, Kumamoto, Japan
Iwamoto Clinic, Kagawa, DIAB I.M.
🇯🇵Kagawa, Zentsuji, Japan
Tenpozan Clinic of I.M., Kagoshima, I.M.
🇯🇵Kagoshima, Kagoshima, Japan
Hayashi DIA Clinic, Kanagawa, DIA Tract Med.·I.M.
🇯🇵Kanagawa, Chigasaki, Japan
Motomachi Takatsuka Naika Clinic, Kanagawa, I.M.
🇯🇵Kanagawa, Yokohama, Japan
Kajiyama Clinic, Kyoto, I.M.
🇯🇵Kyoto, Kyoto, Japan
Matsumoto Nakagawa Hospital
🇯🇵Nagano, Matsumoto, Japan
Saiseikai Niigata Daini Hp., Niigata, METAB ENDO
🇯🇵Niigata, Niigata, Japan
Tsuyama Chuo Hospital
🇯🇵Okayama, Tsuyama, Japan
Yokohama Minoru Clinic
🇯🇵Kanagawa, Yokohama, Japan
Ota DIA I.M. Clinic, Nagano, I.M.
🇯🇵Nagano, Nagano, Japan
Nanko Clinic, Osaka, I.M.
🇯🇵Osaka, Osaka, Japan
Yaesu Clinic, Okinawa, I.M.
🇯🇵Okinawa, Naha, Japan
Tanaka Clinic, Okinawa, I.M.
🇯🇵Okinawa, Tomigusuku, Japan
Umeda Oak Clinic, Osaka, I.M.
🇯🇵Osaka, Osaka, Japan
Ikeoka Clinic, Osaka, I.M.
🇯🇵Osaka, Osaka, Japan
Shiraiwa Medical Clinic, Osaka, I.M.
🇯🇵Osaka, Japan
Medical corporation Chisei-kai Watanabe clinic
🇯🇵Saitama, Okegawa, Japan
Kinugawa CARDIOL Clinic, Osaka, I.M.
🇯🇵Osaka, Osaka, Japan
OCROM Clinic
🇯🇵Osaka, Suita, Japan
AMC Nishi-umeda Clinic
🇯🇵Osaka, Japan
Saga Memorial Hospital
🇯🇵Saga, Saga, Japan
SAINO Clinic,
🇯🇵Saitama, Tokorozawa, Japan
Shinkoiwa Ekimae Sougou Clinic
🇯🇵Tokyo, Katushika-ku, Japan
Plumeria Clinic, Shizuoka, I.M.
🇯🇵Shizuoka, Shizuoka, Japan
Wakakusa Clinic, Tochigi, I.M.
🇯🇵Tochigi, Shimotsuke, Japan
Nihonbashi Enomoto Internal Medicine
🇯🇵Tokyo, Chuo-ku, Japan
New Medical Research System Clinic
🇯🇵Tokyo, Hachioji, Japan
Medical Corporation Keikokai P1-Clinic
🇯🇵Tokyo, Hachioji, Japan
Minamino Heart Clinic
🇯🇵Tokyo, Hachioji, Japan
Hosono Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Shinagawa East one Medical Clinic
🇯🇵Tokyo, Minato-ku, Japan
Kasai Diabetes Clinic
🇯🇵Tokyo, Edogawa-ku, Japan
Musashino Polyclinic
🇯🇵Tokyo, Kiyose, Japan
Miho Clinic
🇯🇵Tokyo, Shinagawa-ku, Japan
Shimamura Kinen Hospital
🇯🇵Tokyo, Nerima-ku, Japan
Kenkoukan Suzuki Clinic
🇯🇵Tokyo, Ota-ku, Japan
Sakayori Clinic
🇯🇵Tokyo, Shinagawa-ku, Japan
ToCROM Clinic
🇯🇵Tokyo, Shinjuku-ku, Japan
Ikebukuro Metropolitan Clinic
🇯🇵Tokyo, Toshima-ku, Japan
Fujikoshi Hp., Toyama, I.M.
🇯🇵Toyama, Toyama, Japan
Matsuyama Shimin Hospital
🇯🇵Ehime, Matsuyama, Japan
Medical Corporation Toujinkai Sakado Central Hospital
🇯🇵Saitama, Sakado, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Tokyo Center Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Pedi Shiodome Clinic
🇯🇵Tokyo, Minato-ku, Japan