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

NCT ID: NCT01734785

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

607 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-08

Study Completion Date

2015-03-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Linagliptin

5 mg once daily

Group Type ACTIVE_COMPARATOR

Linagliptin

Intervention Type DRUG

tablet

Empagliflozin placebo + Linagliptin placebo

Intervention Type DRUG

Matching Empagliflozin + Linagliptin low dose

Empagliflozin + Linagliptin low dose

1 tablet once daily

Group Type EXPERIMENTAL

Empagliflozin + Linagliptin

Intervention Type DRUG

Fixed dose combination.

Empagliflozin + Linagliptin

Intervention Type DRUG

Fixed dose combination

Empagliflozin + Linagliptin high dose

1 tablet once daily

Group Type EXPERIMENTAL

Empagliflozin + Linagliptin

Intervention Type DRUG

Fixed dose combination

Empagliflozin + Linagliptin

Intervention Type DRUG

Fixed dose combination.

Interventions

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Linagliptin

tablet

Intervention Type DRUG

Empagliflozin + Linagliptin

Fixed dose combination.

Intervention Type DRUG

Empagliflozin + Linagliptin

Fixed dose combination

Intervention Type DRUG

Empagliflozin + Linagliptin

Fixed dose combination

Intervention Type DRUG

Empagliflozin placebo + Linagliptin placebo

Matching Empagliflozin + Linagliptin low dose

Intervention Type DRUG

Empagliflozin + Linagliptin

Fixed dose combination.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1275.9.01013 Boehringer Ingelheim Investigational Site

Gulf Shores, Alabama, United States

Site Status

1275.9.01009 Boehringer Ingelheim Investigational Site

Norwalk, California, United States

Site Status

1275.9.01015 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1275.9.01017 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1275.9.01011 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Site Status

1275.9.01010 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Site Status

1275.9.01004 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1275.9.01006 Boehringer Ingelheim Investigational Site

Oldsmar, Florida, United States

Site Status

1275.9.01001 Boehringer Ingelheim Investigational Site

Palm Coast, Florida, United States

Site Status

1275.9.01027 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Site Status

1275.9.01029 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

Site Status

1275.9.01003 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Site Status

1275.9.01022 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Site Status

1275.9.01031 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1275.9.01019 Boehringer Ingelheim Investigational Site

Methuen, Massachusetts, United States

Site Status

1275.9.01024 Boehringer Ingelheim Investigational Site

Troy, Michigan, United States

Site Status

1275.9.01023 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1275.9.01002 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Site Status

1275.9.01007 Boehringer Ingelheim Investigational Site

Newington, New Hampshire, United States

Site Status

1275.9.01016 Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

Site Status

1275.9.01025 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Site Status

1275.9.01014 Boehringer Ingelheim Investigational Site

Shelby, North Carolina, United States

Site Status

1275.9.01028 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

1275.9.01018 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Site Status

1275.9.01005 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

Site Status

1275.9.01032 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Site Status

1275.9.01030 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1275.9.01021 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1275.9.61009 Boehringer Ingelheim Investigational Site

Liverpool, New South Wales, Australia

Site Status

1275.9.61001 Boehringer Ingelheim Investigational Site

St Leonards, New South Wales, Australia

Site Status

1275.9.61003 Boehringer Ingelheim Investigational Site

Carina Heights, Queensland, Australia

Site Status

1275.9.61002 Boehringer Ingelheim Investigational Site

Herston, Queensland, Australia

Site Status

1275.9.61006 Boehringer Ingelheim Investigational Site

Malvern, Victoria, Australia

Site Status

1275.9.61007 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

Site Status

1275.9.55002 Boehringer Ingelheim Investigational Site

Brasília, , Brazil

Site Status

1275.9.55005 Boehringer Ingelheim Investigational Site

Goiânia, , Brazil

Site Status

1275.9.55001 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

1275.9.55003 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

1275.9.55004 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

1275.9.01101 Boehringer Ingelheim Investigational Site

Burnaby, British Columbia, Canada

Site Status

1275.9.01103 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Site Status

1275.9.01105 Boehringer Ingelheim Investigational Site

Cornwall, Ontario, Canada

Site Status

1275.9.01106 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1275.9.01104 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1275.9.01102 Boehringer Ingelheim Investigational Site

Waterloo, Ontario, Canada

Site Status

1275.9.34008 Boehringer Ingelheim Investigational Site

Barcelona, , El Salvador

Site Status

1275.9.33006 Boehringer Ingelheim Investigational Site

Bourg-des-Comptes, , France

Site Status

1275.9.33008 Boehringer Ingelheim Investigational Site

Dessenheim, , France

Site Status

1275.9.33003 Boehringer Ingelheim Investigational Site

La Riche, , France

Site Status

1275.9.33012 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1275.9.33002 Boehringer Ingelheim Investigational Site

Saint-Avertin, , France

Site Status

1275.9.33005 Boehringer Ingelheim Investigational Site

Savonnières, , France

Site Status

1275.9.33004 Boehringer Ingelheim Investigational Site

Tours, , France

Site Status

1275.9.64005 Boehringer Ingelheim Investigational Site

Auckland, New Zealand, , New Zealand

Site Status

1275.9.64006 Boehringer Ingelheim Investigational Site

Auckland, New Zealand, , New Zealand

Site Status

1275.9.64008 Boehringer Ingelheim Investigational Site

Birkenhead Auckland, , New Zealand

Site Status

1275.9.64007 Boehringer Ingelheim Investigational Site

Christchurch Central, , New Zealand

Site Status

1275.9.64004 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand, , New Zealand

Site Status

1275.9.64002 Boehringer Ingelheim Investigational Site

Otahuhu Auckland, , New Zealand

Site Status

1275.9.64001 Boehringer Ingelheim Investigational Site

Takapuna Auckland, , New Zealand

Site Status

1275.9.64003 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand, , New Zealand

Site Status

1275.9.47001 Boehringer Ingelheim Investigational Site

Bergen, , Norway

Site Status

1275.9.47002 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1275.9.47003 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1275.9.47007 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1275.9.47006 Boehringer Ingelheim Investigational Site

Svelvik, , Norway

Site Status

1275.9.82006 Boehringer Ingelheim Investigational Site

Daejeon, , South Korea

Site Status

1275.9.82009 Boehringer Ingelheim Investigational Site

Deagu, , South Korea

Site Status

1275.9.82002 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

Site Status

1275.9.82004 Boehringer Ingelheim Investigational Site

Seongnam, , South Korea

Site Status

1275.9.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1275.9.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1275.9.82007 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1275.9.82008 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1275.9.82010 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1275.9.34011 Boehringer Ingelheim Investigational Site

A Coruña, , Spain

Site Status

1275.9.34009 Boehringer Ingelheim Investigational Site

Alicante, , Spain

Site Status

1275.9.34005 Boehringer Ingelheim Investigational Site

Badía Del Vallès - Barcelona, , Spain

Site Status

1275.9.34001 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1275.9.34003 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1275.9.34004 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1275.9.34002 Boehringer Ingelheim Investigational Site

Seville, , Spain

Site Status

1275.9.34010 Boehringer Ingelheim Investigational Site

Valencia, , Spain

Site Status

1275.9.34006 Boehringer Ingelheim Investigational Site

Vic, , Spain

Site Status

1275.9.88606 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1275.9.88607 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1275.9.88602 Boehringer Ingelheim Investigational Site

New Taipei City, , Taiwan

Site Status

1275.9.88603 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1275.9.88604 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1275.9.88605 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

Countries

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United States Australia Brazil Canada El Salvador France New Zealand Norway South Korea Spain Taiwan

References

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Softeland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.

Reference Type DERIVED
PMID: 27913576 (View on PubMed)

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2012-002270-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1275.9

Identifier Type: -

Identifier Source: org_study_id

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