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

January 4, 2019 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Fukuoka, Japan, 819-0168
        • Kunisaki Makoto Clinic
      • Fukushima, Koriyama, Japan, 963-8851
        • Seino I.M. Clinic, Fukushima, I.M.
      • Hiroshima, Fukuyama, Japan, 721-0927
        • Nippon Kokan Fukuyama Hospital
      • Ibaraki, Naka, Japan, 311-0113
        • Nakakinen clinic
      • Kanagawa, Kawasaki, Japan, 214-0014
        • Kubota Clinic
      • Kanagawa, Yamato-shi, Japan, 242-0004
        • Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
      • Kanagawa, Yokohama, Japan, 232-0064
        • Yokohama Minoru Clinic
      • Mie, Yokkaichi, Japan, 510-0829
        • Yokkaichi Diabetes Clinic
      • Osaka, Kashiwara-shi, Japan, 582-0005
        • Shiraiwa Medical Clinic
      • Osaka, Osaka-shi, Japan, 530-0001
        • AMC NISHI-UMEDA Clinic
      • Osaka, Suita, Japan, 565-0853
        • OCROM Clinic
      • Tokyo, Chuo-ku, Japan, 103-0027
        • Fukuwa Clinic
      • Tokyo, Chuo-ku, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Tokyo, Hachioji, Japan, 192-0918
        • Minamino Heart Clinic
      • Tokyo, Shinjuku-ku, Japan, 169-0073
        • Shinjuku Research Park Clinic
      • Tokyo, Shinjuku-ku, Japan, 160-0022
        • ToCROM Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: empagliflozin 10 mg
empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
Drug: Placebo
For blinding purposes
Drug: empagliflozin 10mg
Experimental: empagliflozin 25 mg
empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet
Drug: Placebo
For blinding purposes
Drug: empagliflozin 25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
Time Frame: 52 weeks
Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c After 52 Weeks of Treatment
Time Frame: baseline and 52 weeks
Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.
baseline and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2015

Primary Completion (Actual)

June 2, 2017

Study Completion (Actual)

June 2, 2017

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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