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

• Status: Completed
• Trial end date: 2017-06-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Empagliflozin; Glucagon-Like Peptide 1

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