Clinical Trial Details
| Trial ID: | L3060 |
| Source ID: | NCT02589626 |
| Associated Drug: | Empagliflozin 10mg |
| Title: | Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02589626/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: empagliflozin 10mg|DRUG: empagliflozin 25 mg|DRUG: Placebo |
| Outcome Measures: | Primary: Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment, Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented, 52 weeks | Secondary: Change From Baseline in HbA1c After 52 Weeks of Treatment, Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means., baseline and 52 weeks |
| Sponsor/Collaborators: | Sponsor: Boehringer Ingelheim |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 65 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT |
| Start Date: | 2015-10-29 |
| Completion Date: | 2017-06-02 |
| Results First Posted: | 2019-01-07 |
| Last Update Posted: | 2019-01-07 |
| Locations: | Kunisaki Makoto Clinic, Fukuoka, Fukuoka, 819-0168, Japan|Seino I.M. Clinic, Fukushima, I.M., Fukushima, Koriyama, 963-8851, Japan|Nippon Kokan Fukuyama Hospital, Hiroshima, Fukuyama, 721-0927, Japan|Nakakinen Clinic, Ibaraki, Naka, 311-0113, Japan|Kubota Clinic, Kanagawa, Kawasaki, 214-0014, Japan|Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic, Kanagawa, Yamato-shi, 242-0004, Japan|Yokohama Minoru Clinic, Kanagawa, Yokohama, 232-0064, Japan|Yokkaichi Diabetes Clinic, Mie, Yokkaichi, 510-0829, Japan|Shiraiwa Medical Clinic, Osaka, Kashiwara-shi, 582-0005, Japan|AMC Nishi-umeda Clinic, Osaka, Osaka-shi, 530-0001, Japan|OCROM Clinic, Osaka, Suita, 565-0853, Japan|Fukuwa Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Tokyo-Eki Center-building Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Minamino Heart Clinic, Tokyo, Hachioji, 192-0918, Japan|ToCROM Clinic, Tokyo, Shinjuku-ku, 160-0022, Japan|Shinjuku Research Park Clinic, Tokyo, Shinjuku-ku, 169-0073, Japan |
| URL: | https://clinicaltrials.gov/show/NCT02589626 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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