Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: empagliflozin 10mg; Drug: empagliflozin 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02589626

1245.106

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups

empagliflozin 10 mg

Experimental group

Description:

empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet

Treatment:

Drug: empagliflozin 10mg

Drug: Placebo

empagliflozin 25 mg

Experimental group

Description:

empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet

Treatment:

Drug: empagliflozin 25 mg

Drug: Placebo