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Clinical Trial Details

Trial ID: L3682
Source ID: NCT02489968
Associated Drug: Empagliflozin 10 Mg + Linagliptin 5 Mg
Title: Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02489968/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: empagliflozin 10 mg + linagliptin 5 mg|DRUG: empagliflozin 10 mg|DRUG: empagliflozin 25 mg + linagliptin 5 mg|DRUG: empagliflozin 25 mg|DRUG: Placebo
Outcome Measures: Primary: Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment, 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., Baseline and 24 week |
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 880
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-05-12
Completion Date: 2017-06-16
Results First Posted: 2018-09-06
Last Update Posted: 2018-09-06
Locations: Tokai Memorial Hospital, Aichi, Kasugai, 487-0031, Japan|Japan Organization of Occupational Health and Safety Chubu Rosai Hospital, Aichi, Nagoya, 455-8530, Japan|Tokuyama Clinic, Chiba, Chiba, 261-0004, Japan|Matsuyama Shimin Hospital, Ehime, Matsuyama, 790-0067, Japan|Tanaka Int. Clinic, Ehime, DIA Med.,CV Med., Ehime, Niihama, 792-0045, Japan|Murakami Memorial Hp., Ehime, I.M., Ehime, Saijo, 793-0030, Japan|Kunisaki Makoto Clinic, Fukuoka, I.M./CV Med., Fukuoka, Fukuoka, 819-0168, Japan|Fukuoka Shin Mizumaki Hospital, Fukuoka, Onga, 807-0051, Japan|Shin Yukuhashi Hospital, Fukuoka, Yukuhashi, 824-0026, Japan|Hashimoto I.M., Gifu, I.M., Gifu, Gifu, 500-8225, Japan|Kikuchi Naika Clinic, Gunma, I.M., Gunma, Maebashi, 370-3573, Japan|Hasegawa Internal Medicine Clinic, Hokkaido, Chitose, 066-0032, Japan|Ebetsu Internal Medicine Clinic, Hokkaido, Ebetsu, 067-0041, Japan|Hakodate Koseiin Hakodate Central General Hospital, Hokkaido, Hakodate, 040-8585, Japan|Iida Medical Clinic, Hokkaido, Hakodate, 042-0942, Japan|Kurihara Clinic, Hokkaido, Sapporo, 004-0053, Japan|Uehara Clinic, Hokkaido, Sapporo, 006-0031, Japan|Manda Memorial Hospital, Hokkaido, Sapporo, 060-0062, Japan|Sapporo Diabetes, Thyroid Clinic, Hokkaido, Sapporo, 060-0807, Japan|Japan Community Health Care Organization Hokkaido Hospital, Hokkaido, Sapporo, 062-8618, Japan|Ashiya Municipal Hospital, Hyogo, Ashiya, 659-8502, Japan|Itabashi DIA Med. and DERM Clinic, Ibaraki, I.M., Ibaraki, Koga, 306-0232, Japan|Namegata District General Hospital, Ibaraki, Namegata, 311-3516, Japan|Hokuriku Hp., Ishikawa, I.M., Ishikawa, Kanazawa, 921-8035, Japan|Oikawa Clinic, Iwate, Morioka, 020-0066, Japan|Hirano Medical Clinic, Iwate, Morioka, 020-0132, Japan|Iwamoto Clinic, Kagawa, DIAB I.M., Kagawa, Zentsuji, 765-0071, Japan|Tenpozan Clinic of I.M., Kagoshima, I.M., Kagoshima, Kagoshima, 890-0061, Japan|Hayashi DIA Clinic, Kanagawa, DIA Tract Med.·I.M., Kanagawa, Chigasaki, 253-0044, Japan|Takai Naika Clinic, Kanagawa, Kamakura, 247-0056, Japan|Nagatsuta Family Clinic, Kanagawa, I.M., Kanagawa, Yokohama, 226-0027, Japan|Motomachi Takatsuka Naika Clinic, Kanagawa, I.M., Kanagawa, Yokohama, 231-0023, Japan|Yokohama Minoru Clinic, Kanagawa, Yokohama, 232-0064, Japan|Morinagaueno clinic, Kumamoto, Digestive Tract I.M., Kumamoto, Kumamoto, 860-0863, Japan|Kumamoto University Hospital, Kumamoto, Kumamoto, 860-8556, Japan|Jinnouchi Clinic Diabetes Care Center, Kumamoto, Kumamoto, 862-0976, Japan|Kajiyama Clinic, Kyoto, I.M., Kyoto, Kyoto, 615-0035, Japan|Matsumoto Nakagawa Hospital, Nagano, Matsumoto, 399-0006, Japan|Ota DIA I.M. Clinic, Nagano, I.M., Nagano, Nagano, 380-0802, Japan|Saiseikai Niigata Daini Hp., Niigata, METAB ENDO, Niigata, Niigata, 950-1104, Japan|Tsuyama Chuo Hospital, Okayama, Tsuyama, 708-0841, Japan|Yaesu Clinic, Okinawa, I.M., Okinawa, Naha, 900-0032, Japan|Tanaka Clinic, Okinawa, I.M., Okinawa, Tomigusuku, 901-0244, Japan|Umeda Oak Clinic, Osaka, I.M., Osaka, Osaka, 530-0057, Japan|Kinugawa CARDIOL Clinic, Osaka, I.M., Osaka, Osaka, 532-0026, Japan|Ikeoka Clinic, Osaka, I.M., Osaka, Osaka, 536-0008, Japan|Nanko Clinic, Osaka, I.M., Osaka, Osaka, 559-0011, Japan|OCROM Clinic, Osaka, Suita, 565-0853, Japan|AMC Nishi-umeda Clinic, Osaka, 530-0001, Japan|Shiraiwa Medical Clinic, Osaka, I.M., Osaka, 582-0005, Japan|Saga Memorial Hospital, Saga, Saga, 849-0917, Japan|Odayaka Life Naika Clinic, Saitama, I.M., Saitama, Koshigaya, 343-0828, Japan|Medical corporation Chisei-kai Watanabe clinic, Saitama, Okegawa, 363-0022, Japan|Medical Corporation Toujinkai Sakado Central Hospital, Saitama, Sakado, 350-0233, Japan|SAINO Clinic,, Saitama, Tokorozawa, 359-1141, Japan|Hamamatsu Rosai Hospital, Shizuoka, Hamamatsu, 430-8525, Japan|Plumeria Clinic, Shizuoka, I.M., Shizuoka, Shizuoka, 422-8006, Japan|Wakakusa Clinic, Tochigi, I.M., Tochigi, Shimotsuke, 329-0433, Japan|Nihonbashi Sakura Clinic, Tokyo, Chuo-ku, 103-0025, Japan|Fukuwa Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Nihonbashi Enomoto Internal Medicine, Tokyo, Chuo-ku, 103-0027, Japan|Tokyo-Eki Center-building Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Tokyo Center Clinic, Tokyo, Chuo-ku, 103-0028, Japan|Hosono Clinic, Tokyo, Chuo-ku, 104-0031, Japan|AGE Makita Medical Clinic, Tokyo, Chuo-ku, 104-0061, Japan|Kasai Diabetes Clinic, Tokyo, Edogawa-ku, 134-0084, Japan|New Medical Research System Clinic, Tokyo, Hachioji, 192-0046, Japan|Medical Corporation Keikokai P1-Clinic, Tokyo, Hachioji, 192-0071, Japan|Minamino Heart Clinic, Tokyo, Hachioji, 192-0918, Japan|Shinkoiwa Ekimae Sougou Clinic, Tokyo, Katushika-ku, 124-0024, Japan|Musashino Polyclinic, Tokyo, Kiyose, 204-0021, Japan|Pedi Shiodome Clinic, Tokyo, Minato-ku, 105-7390, Japan|Shinagawa East one Medical Clinic, Tokyo, Minato-ku, 108-0075, Japan|Shimamura Kinen Hospital, Tokyo, Nerima-ku, 177-0051, Japan|Kenkoukan Suzuki Clinic, Tokyo, Ota-ku, 143-0015, Japan|Honda Hidehiko Clinic, Tokyo, Ota-ku, 143-0023, Japan|Sakayori Clinic, Tokyo, Shinagawa-ku, 140-0011, Japan|Miho Clinic, Tokyo, Shinagawa-ku, 141-0032, Japan|ToCROM Clinic, Tokyo, Shinjuku-ku, 160-0022, Japan|Ikebukuro Metropolitan Clinic, Tokyo, Toshima-ku, 171-0021, Japan|Kanda Clinic, Tokyo, I.M., Tokyo, 101-0047, Japan|Fujikoshi Hp., Toyama, I.M., Toyama, Toyama, 930-0964, Japan|Clinic Sugiyama, Yamagata, I.M., Yamagata, Yamagata, 990-0885, Japan
URL: https://clinicaltrials.gov/show/NCT02489968