Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments empagliflozin 10mg, empagliflozin 25 mg, placebo
Phase phase 4
Sponsor Boehringer Ingelheim
Start date October 2015
End date June 2017
Trial size 64 participants
Trial identifier NCT02589626, 1245.106

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment
Arm
(Experimental)
empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
empagliflozin 10mg
placebo
For blinding purposes
(Experimental)
empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet
empagliflozin 25 mg
placebo
For blinding purposes

Primary Outcomes

Measure
Proportion of patients with drug-related adverse events
time frame: 52 weeks

Secondary Outcomes

Measure
Change in HbA1c
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

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, 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 eGFR <45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period - Further exclusion criteria apply

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.