Clinical trial NCT02589626: Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA
Official title: A 52-week Randomised, Double-blind, Parallel Group, Safety and Efficacy Study of Empagliflozin Once Daily as add-on Therapy to Glucagon-like Peptide-1 Receptor Agonist in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-10-28
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control


Eligibility criteria: Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus
* 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
* Further inclusion criteria apply

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose values \>270 mg/dL (\>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement
* 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
* Further exclusion criteria apply

Primary outcomes:
measure: Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
timeFrame: 52 weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c After 52 Weeks of Treatment
timeFrame: baseline and 52 weeks
Other outcomes:
Locations:
city: Fukuoka, Fukuoka
country: Japan
facility: Kunisaki Makoto Clinic
city: Fukushima, Koriyama
country: Japan
facility: Seino I.M. Clinic, Fukushima, I.M.
city: Hiroshima, Fukuyama
country: Japan
facility: Nippon Kokan Fukuyama Hospital
city: Ibaraki, Naka
country: Japan
facility: Nakakinen Clinic
city: Kanagawa, Kawasaki
country: Japan
facility: Kubota Clinic
city: Kanagawa, Yamato-shi
country: Japan
facility: Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
city: Kanagawa, Yokohama
country: Japan
facility: Yokohama Minoru Clinic
city: Mie, Yokkaichi
country: Japan
facility: Yokkaichi Diabetes Clinic
city: Osaka, Kashiwara-shi
country: Japan
facility: Shiraiwa Medical Clinic
city: Osaka, Osaka-shi
country: Japan
facility: AMC Nishi-umeda Clinic
city: Osaka, Suita
country: Japan
facility: OCROM Clinic
city: Tokyo, Chuo-ku
country: Japan
facility: Fukuwa Clinic
city: Tokyo, Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo, Hachioji
country: Japan
facility: Minamino Heart Clinic
city: Tokyo, Shinjuku-ku
country: Japan
facility: ToCROM Clinic
city: Tokyo, Shinjuku-ku
country: Japan
facility: Shinjuku Research Park Clinic
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.