Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

June 9, 2016 updated by: Boehringer Ingelheim

A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

607

Phase

  • Phase 3

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

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia
        • 1275.9.61009 Boehringer Ingelheim Investigational Site
      • St Leonards, New South Wales, Australia
        • 1275.9.61001 Boehringer Ingelheim Investigational Site
    • Queensland
      • Carina Heights, Queensland, Australia
        • 1275.9.61003 Boehringer Ingelheim Investigational Site
      • Herston, Queensland, Australia
        • 1275.9.61002 Boehringer Ingelheim Investigational Site
    • Victoria
      • Malvern, Victoria, Australia
        • 1275.9.61006 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • 1275.9.61007 Boehringer Ingelheim Investigational Site
  • Brazil
      • Brasilia, Brazil
        • 1275.9.55002 Boehringer Ingelheim Investigational Site
      • Goiania, Brazil
        • 1275.9.55005 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1275.9.55001 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1275.9.55003 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 1275.9.55004 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada
        • 1275.9.01101 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 1275.9.01103 Boehringer Ingelheim Investigational Site
    • Ontario
      • Cornwall, Ontario, Canada
        • 1275.9.01105 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1275.9.01106 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1275.9.01104 Boehringer Ingelheim Investigational Site
      • Waterloo, Ontario, Canada
        • 1275.9.01102 Boehringer Ingelheim Investigational Site
  • El Salvador
      • Barcelona, El Salvador
        • 1275.9.34008 Boehringer Ingelheim Investigational Site
  • France
      • Bourg des Comptes, France
        • 1275.9.33006 Boehringer Ingelheim Investigational Site
      • Dessenheim, France
        • 1275.9.33008 Boehringer Ingelheim Investigational Site
      • La Riche, France
        • 1275.9.33003 Boehringer Ingelheim Investigational Site
      • Paris, France
        • 1275.9.33012 Boehringer Ingelheim Investigational Site
      • Saint Avertin, France
        • 1275.9.33002 Boehringer Ingelheim Investigational Site
      • Savonnieres, France
        • 1275.9.33005 Boehringer Ingelheim Investigational Site
      • Tours, France
        • 1275.9.33004 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • 1275.9.82006 Boehringer Ingelheim Investigational Site
      • Deagu, Korea, Republic of
        • 1275.9.82009 Boehringer Ingelheim Investigational Site
      • Goyang, Korea, Republic of
        • 1275.9.82002 Boehringer Ingelheim Investigational Site
      • Seongnam, Korea, Republic of
        • 1275.9.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1275.9.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1275.9.82005 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1275.9.82007 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1275.9.82008 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1275.9.82010 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Auckland, New Zealand, New Zealand
        • 1275.9.64005 Boehringer Ingelheim Investigational Site
      • Auckland, New Zealand, New Zealand
        • 1275.9.64006 Boehringer Ingelheim Investigational Site
      • Birkenhead Auckland, New Zealand
        • 1275.9.64008 Boehringer Ingelheim Investigational Site
      • Christchurch Central, New Zealand
        • 1275.9.64007 Boehringer Ingelheim Investigational Site
      • Christchurch, New Zealand, New Zealand
        • 1275.9.64004 Boehringer Ingelheim Investigational Site
      • Otahuhu Auckland, New Zealand
        • 1275.9.64002 Boehringer Ingelheim Investigational Site
      • Takapuna Auckland, New Zealand
        • 1275.9.64001 Boehringer Ingelheim Investigational Site
      • Tauranga, New Zealand, New Zealand
        • 1275.9.64003 Boehringer Ingelheim Investigational Site
  • Norway
      • Bergen, Norway
        • 1275.9.47001 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 1275.9.47002 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 1275.9.47003 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 1275.9.47007 Boehringer Ingelheim Investigational Site
      • Svelvik, Norway
        • 1275.9.47006 Boehringer Ingelheim Investigational Site
  • Spain
      • A Coruña, Spain
        • 1275.9.34011 Boehringer Ingelheim Investigational Site
      • Alicante, Spain
        • 1275.9.34009 Boehringer Ingelheim Investigational Site
      • Badía del Vallès - Barcelona, Spain
        • 1275.9.34005 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1275.9.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1275.9.34003 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1275.9.34004 Boehringer Ingelheim Investigational Site
      • Sevilla, Spain
        • 1275.9.34002 Boehringer Ingelheim Investigational Site
      • Valencia, Spain
        • 1275.9.34010 Boehringer Ingelheim Investigational Site
      • Vic, Spain
        • 1275.9.34006 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan
        • 1275.9.88606 Boehringer Ingelheim Investigational Site
      • Kaohsiung, Taiwan
        • 1275.9.88607 Boehringer Ingelheim Investigational Site
      • New Taipei, Taiwan
        • 1275.9.88602 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1275.9.88603 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1275.9.88604 Boehringer Ingelheim Investigational Site
      • Tainan, Taiwan
        • 1275.9.88605 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Gulf Shores, Alabama, United States
        • 1275.9.01013 Boehringer Ingelheim Investigational Site
    • California
      • Norwalk, California, United States
        • 1275.9.01009 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 1275.9.01015 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 1275.9.01017 Boehringer Ingelheim Investigational Site
    • Colorado
      • Northglenn, Colorado, United States
        • 1275.9.01011 Boehringer Ingelheim Investigational Site
    • Florida
      • Coral Gables, Florida, United States
        • 1275.9.01010 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1275.9.01004 Boehringer Ingelheim Investigational Site
      • Oldsmar, Florida, United States
        • 1275.9.01006 Boehringer Ingelheim Investigational Site
      • Palm Coast, Florida, United States
        • 1275.9.01001 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, United States
        • 1275.9.01027 Boehringer Ingelheim Investigational Site
    • Georgia
      • Blue Ridge, Georgia, United States
        • 1275.9.01029 Boehringer Ingelheim Investigational Site
      • Marietta, Georgia, United States
        • 1275.9.01003 Boehringer Ingelheim Investigational Site
      • Savannah, Georgia, United States
        • 1275.9.01022 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1275.9.01031 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Methuen, Massachusetts, United States
        • 1275.9.01019 Boehringer Ingelheim Investigational Site
    • Michigan
      • Troy, Michigan, United States
        • 1275.9.01024 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 1275.9.01023 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1275.9.01002 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Newington, New Hampshire, United States
        • 1275.9.01007 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States
        • 1275.9.01016 Boehringer Ingelheim Investigational Site
      • Burlington, North Carolina, United States
        • 1275.9.01025 Boehringer Ingelheim Investigational Site
      • Shelby, North Carolina, United States
        • 1275.9.01014 Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • 1275.9.01028 Boehringer Ingelheim Investigational Site
    • Ohio
      • Dayton, Ohio, United States
        • 1275.9.01018 Boehringer Ingelheim Investigational Site
    • Oregon
      • Corvallis, Oregon, United States
        • 1275.9.01005 Boehringer Ingelheim Investigational Site
    • Texas
      • Corpus Christi, Texas, United States
        • 1275.9.01032 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1275.9.01030 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1275.9.01021 Boehringer Ingelheim Investigational Site

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus.
  2. Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
  3. HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
  4. Age 18 years or more at screening.
  5. Body Mass Index lower or equal to 45 kg/m2 at screening visit.
  6. Signed and dated written informed consent.

Exclusion criteria:

  1. Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
  2. Use of any other antidiabetic drug (except metformin background therapy).
  3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
  4. Indication of liver disease.
  5. Impaired renal function.
  6. Gastrointestinal surgery.
  7. Treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
  8. Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.

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
Active Comparator: Linagliptin
5 mg once daily
Drug: Linagliptin
tablet
Drug: Empaglifozin placebo + Linagliptin placebo
Matching Empaglifozin + Linagliptin low dose
Experimental: Empaglifozin + Linagliptin low dose
1 tablet once daily
Drug: Empagliflozin + Linagliptin
Fixed dose combination.
Drug: Empagliflozin + Linagliptin
Fixed dose combination
Experimental: Empagliflozin + Linagliptin high dose
1 tablet once daily
Drug: Empagliflozin + Linagliptin
Fixed dose combination.
Drug: Empagliflozin + Linagliptin
Fixed dose combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
Time Frame: Baseline and 24 weeks
Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.
Time Frame: Baseline and 24 weeks
Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.
Baseline and 24 weeks
Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment
Time Frame: Baseline and 24 weeks
Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.
Baseline and 24 weeks

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

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

January 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1275.9
  • 2012-002270-31 (EudraCT Number: EudraCT)

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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