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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
607

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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