Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA
NCT ID: NCT02589626
Last Updated: 2019-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
65 participants
INTERVENTIONAL
2015-10-29
2017-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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empagliflozin 10 mg
empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
empagliflozin 10mg
Placebo
For blinding purposes
empagliflozin 25 mg
empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet
empagliflozin 25 mg
Placebo
For blinding purposes
Interventions
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empagliflozin 10mg
empagliflozin 25 mg
Placebo
For blinding purposes
Eligibility Criteria
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Inclusion Criteria
* Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be \>=7.0% and \<=10.0% at screening
* Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=9.0% at screening and \>=7.0% and \<=10.0% at placebo run-in
* Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be \>=7.0% and \<=10.0% at both screening and placebo run-in
* Age at informed consent must be \>=20 years
* BMI at screening must be \<=40 kg/m2
Exclusion Criteria
* Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent.
* Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent
* Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period
* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period
20 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Kunisaki Makoto Clinic
Fukuoka, Fukuoka, , Japan
Seino I.M. Clinic, Fukushima, I.M.
Fukushima, Koriyama, , Japan
Nippon Kokan Fukuyama Hospital
Hiroshima, Fukuyama, , Japan
Nakakinen Clinic
Ibaraki, Naka, , Japan
Kubota Clinic
Kanagawa, Kawasaki, , Japan
Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
Kanagawa, Yamato-shi, , Japan
Yokohama Minoru Clinic
Kanagawa, Yokohama, , Japan
Yokkaichi Diabetes Clinic
Mie, Yokkaichi, , Japan
Shiraiwa Medical Clinic
Osaka, Kashiwara-shi, , Japan
AMC Nishi-umeda Clinic
Osaka, Osaka-shi, , Japan
OCROM Clinic
Osaka, Suita, , Japan
Fukuwa Clinic
Tokyo, Chuo-ku, , Japan
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, , Japan
Minamino Heart Clinic
Tokyo, Hachioji, , Japan
ToCROM Clinic
Tokyo, Shinjuku-ku, , Japan
Shinjuku Research Park Clinic
Tokyo, Shinjuku-ku, , Japan
Countries
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References
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Terauchi Y, Utsunomiya K, Yasui A, Seki T, Cheng G, Shiki K, Lee J. Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study. Diabetes Ther. 2019 Jun;10(3):951-963. doi: 10.1007/s13300-019-0604-8. Epub 2019 Mar 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1245.106
Identifier Type: -
Identifier Source: org_study_id
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