Clinical Trial Details
| Trial ID: | L4904 |
| Source ID: | NCT02453555 |
| Associated Drug: | Linagliptin |
| Title: | Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02453555/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Linagliptin|DRUG: Empagliflozin placebo + linagliptin placebo low dose|DRUG: Empagliflozin + linagliptin low dose|DRUG: Linagliptin placebo|DRUG: Empagliflozin + linagliptin high dose|DRUG: Empa + lina highdose placebo |
| Outcome Measures: | Primary: Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline), Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented., Baseline and 24 week | Secondary: Change in HbA1c From Week 28 at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Only), Change from Week 28 in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at Week 28. Week 28 (pre up-titration) is referred to the last observed measurement prior to the first administration of any double-blind randomized trial medication in the up-titration period. Adjusted mean (Least square mean) and its standard error (SE) is presented. This endpoint was based on 1 group of the Full analysis set with up-titration (FASUT-II) whose dose was up-titrated to Empagliflozin 25 mg/Linagliptin 5 mg fixed dose combination thus there is no comparison group. Hence, no comparison is made. A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline eGFR, prior use of antidiabetic drug, visit as fixed effect(s). The covariance used to fit the model was unstructured., 28 Week (pre up-titration) and 52 Week|Change in HbA1c From Baseline at Week 52 (All Empagliflozin Versus All Placebo), Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented., Baseline and 52 week|Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus Linagliptin 5 mg + Placebo 25 mg), Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented., Baseline and 52 week|Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus All Placebo), Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented., Baseline and 52 week |
| Sponsor/Collaborators: | Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 275 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-05-14 |
| Completion Date: | 2017-03-27 |
| Results First Posted: | 2019-02-15 |
| Last Update Posted: | 2019-02-15 |
| Locations: | Nagoya Kyoritsu Hospital, Aichi, Nagoya, 454-0933, Japan|Kashiwa City Hospital, Chiba, Kashiwa, 277-0825, Japan|Otabe internal medicine clinic, Fukuoka, Fukuoka, 811-1346, Japan|Nakamura Cardiovascular Clinic, Fukuoka, Itoshima, 819-1104, Japan|Tanaka I.M. Clinic, Fukuoka, I.M., Fukuoka, Kurume, 830-0023, Japan|Seino I.M. Clinic, Fukushima, I.M., Fukushima, Koriyama, 963-8851, Japan|Hiraoka Naika Clinic, Hiroshima, I.M., Hiroshima, Hiroshima, 733-0011, Japan|Matsuda Cardiovascular Clinic, Hokkaido, Sapporo, 003-0026, Japan|Teine Keijinkai Clinic, Hokkaido, Sapporo, 006-0811, Japan|Mita Internal Medicine Cardiology Clinic, Hokkaido, Sapporo, 006-0852, Japan|Miyanosawa Clinic of Internal Medicine and Cardiology, Hokkaido, Sapporo, 063-0826, Japan|Itabashi Diabetic medicine and Dermatology Clinic, Ibaraki, Koga, 306-0232, Japan|Nakakinen Clinic, Ibaraki, Naka, 311-0113, Japan|Kubota Clinic, Kanagawa, Kawasaki, 214-0014, Japan|Kitasato University Hospital, Kanagawa, Sagamihara, 252-0375, Japan|H.E.C Science Clinic, Kanagawa, Yokohama, 235-0045, Japan|Yoshimasa Diabetes & Endocrine Clinic, Kyoto, Kyoto, 604-8151, Japan|Rakuwakai Otowa Hospital, Kyoto, Kyoto, 607-8062, Japan|Medical Corporation Hayashi Katagihara Clinic, Kyoto, Kyoto, 615-8125, Japan|Miyamoto Naika Clinic, Nagano, I.M., Nagano, Matsumoto, 390-0848, Japan|Gibo Hepatology Clinic, Nagano, Digestive Tract I.M., Nagano, Matsumoto, 399-0036, Japan|Takekawa Clinic, Osaka, I.M., Osaka, Higashi-Osaka, 577-0803, Japan|Medical Corporation Koseikai Fukuda Naika Clinic, Osaka, Osaka, 532-0003, Japan|Kinugawa Cardiovascular Internal Medicine clinic, Osaka, Osaka, 532-0026, Japan|Sato Hospital, Osaka, Osaka, 536-0023, Japan|Nakaoka Clinic, Osaka, Osaka, 555-0032, Japan|OCROM Clinic, Osaka, Suita, 565-0853, Japan|Miyauchi Medical Center, Osaka, Takatsuki, 569-1123, Japan|Medical Corporation Shinseikai Mashiba Clinic, Saitama, Hanno, 357-0024, Japan|Asano Clinic, Saitama, Kawagoe, 350-0851, Japan|Medical Corporation Fusa Shimizu Clinic Fusa, Saitama, Saitama, 336-0963, Japan|Ogino Clinic, Saitama, Tokorozawa, 359-1161, Japan|Kanda Clinic, Tokyo, Chiyoda-ku, 101-0047, Japan|Fukuwa Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Tokyo-Eki Center-building Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Myojin Tou Clinic, Tokyo, Hachioji, 192-0046, Japan|Sawai Medical Clinic, Tokyo, Koto-ku, 136-0073, Japan|Mishuku Hospital, Tokyo, Meguro-ku, 153-0051, Japan|Toshiba General Hospital, Tokyo, Shinagawa-ku, 140-8522, Japan|ToCROM Clinic, Tokyo, Shinjuku-ku, 160-0022, Japan |
| URL: | https://clinicaltrials.gov/show/NCT02453555 |
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