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

NCT01734785 | Completed Phase 3 Results

• 2 other identifiers: 1275.92012-002270-31
• Study Type: interventional
• Target: 607
• Locations: 11 countries
• Sites: 90

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment

  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 Outcomes (2)

• Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.

  Baseline and 24 weeks

• Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment

  Baseline and 24 weeks

Study Arms (3)

Linagliptin

ACTIVE COMPARATOR

5 mg once daily

Drug: Linagliptin; Drug: Empagliflozin placebo + Linagliptin placebo

Empagliflozin + Linagliptin low dose

EXPERIMENTAL

1 tablet once daily

Drug: Empagliflozin + Linagliptin

Empagliflozin + Linagliptin high dose

EXPERIMENTAL

1 tablet once daily

Drug: Empagliflozin + Linagliptin

Interventions

Linagliptin DRUG

tablet

Linagliptin

Empagliflozin + Linagliptin DRUG

Fixed dose combination.

Empagliflozin + Linagliptin low dose

Empagliflozin placebo + Linagliptin placebo DRUG

Matching Empagliflozin + Linagliptin low dose

Linagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus.
• 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.
• HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
• Age 18 years or more at screening.
• Body Mass Index lower or equal to 45 kg/m2 at screening visit.
• Signed and dated written informed consent.

You may not qualify if:

• Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
• Use of any other antidiabetic drug (except metformin background therapy).
• Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
• Indication of liver disease.
• Impaired renal function.
• Gastrointestinal surgery.
• 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.
• Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (90)

1275.9.01013 Boehringer Ingelheim Investigational Site

Gulf Shores, Alabama, United States

Location

1275.9.01009 Boehringer Ingelheim Investigational Site

Norwalk, California, United States

Location

1275.9.01015 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1275.9.01017 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1275.9.01011 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Location

1275.9.01010 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Location

1275.9.01004 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1275.9.01006 Boehringer Ingelheim Investigational Site

Oldsmar, Florida, United States

Location

1275.9.01001 Boehringer Ingelheim Investigational Site

Palm Coast, Florida, United States

Location

1275.9.01027 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Location

1275.9.01029 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

Location

1275.9.01003 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

1275.9.01022 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Location

1275.9.01031 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1275.9.01019 Boehringer Ingelheim Investigational Site

Methuen, Massachusetts, United States

Location

1275.9.01024 Boehringer Ingelheim Investigational Site

Troy, Michigan, United States

Location

1275.9.01023 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1275.9.01002 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1275.9.01007 Boehringer Ingelheim Investigational Site

Newington, New Hampshire, United States

Location

1275.9.01016 Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

Location

1275.9.01025 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Location

1275.9.01014 Boehringer Ingelheim Investigational Site

Shelby, North Carolina, United States

Location

1275.9.01028 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1275.9.01018 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

1275.9.01005 Boehringer Ingelheim Investigational Site

Corvallis, Oregon, United States

Location

1275.9.01032 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Location

1275.9.01030 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1275.9.01021 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1275.9.61009 Boehringer Ingelheim Investigational Site

Liverpool, New South Wales, Australia

Location

1275.9.61001 Boehringer Ingelheim Investigational Site

St Leonards, New South Wales, Australia

Location

1275.9.61003 Boehringer Ingelheim Investigational Site

Carina Heights, Queensland, Australia

Location

1275.9.61002 Boehringer Ingelheim Investigational Site

Herston, Queensland, Australia

Location

1275.9.61006 Boehringer Ingelheim Investigational Site

Malvern, Victoria, Australia

Location

1275.9.61007 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

Location

1275.9.55002 Boehringer Ingelheim Investigational Site

Brasília, Brazil

Location

1275.9.55005 Boehringer Ingelheim Investigational Site

Goiânia, Brazil

Location

1275.9.55001 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1275.9.55003 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1275.9.55004 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1275.9.01101 Boehringer Ingelheim Investigational Site

Burnaby, British Columbia, Canada

Location

1275.9.01103 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1275.9.01105 Boehringer Ingelheim Investigational Site

Cornwall, Ontario, Canada

Location

1275.9.01106 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1275.9.01104 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1275.9.01102 Boehringer Ingelheim Investigational Site

Waterloo, Ontario, Canada

Location

1275.9.34008 Boehringer Ingelheim Investigational Site

Barcelona, El Salvador

Location

1275.9.33006 Boehringer Ingelheim Investigational Site

Bourg-des-Comptes, France

Location

1275.9.33008 Boehringer Ingelheim Investigational Site

Dessenheim, France

Location

1275.9.33003 Boehringer Ingelheim Investigational Site

La Riche, France

Location

1275.9.33012 Boehringer Ingelheim Investigational Site

Paris, France

Location

1275.9.33002 Boehringer Ingelheim Investigational Site

Saint-Avertin, France

Location

1275.9.33005 Boehringer Ingelheim Investigational Site

Savonnières, France

Location

1275.9.33004 Boehringer Ingelheim Investigational Site

Tours, France

Location

1275.9.64005 Boehringer Ingelheim Investigational Site

Auckland, New Zealand, New Zealand

Location

1275.9.64006 Boehringer Ingelheim Investigational Site

Auckland, New Zealand, New Zealand

Location

1275.9.64008 Boehringer Ingelheim Investigational Site

Birkenhead Auckland, New Zealand

Location

1275.9.64007 Boehringer Ingelheim Investigational Site

Christchurch Central, New Zealand

Location

1275.9.64004 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand, New Zealand

Location

1275.9.64002 Boehringer Ingelheim Investigational Site

Otahuhu Auckland, New Zealand

Location

1275.9.64001 Boehringer Ingelheim Investigational Site

Takapuna Auckland, New Zealand

Location

1275.9.64003 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand, New Zealand

Location

1275.9.47001 Boehringer Ingelheim Investigational Site

Bergen, Norway

Location

1275.9.47002 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1275.9.47003 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1275.9.47007 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1275.9.47006 Boehringer Ingelheim Investigational Site

Svelvik, Norway

Location

1275.9.82006 Boehringer Ingelheim Investigational Site

Daejeon, South Korea

Location

1275.9.82009 Boehringer Ingelheim Investigational Site

Deagu, South Korea

Location

1275.9.82002 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1275.9.82004 Boehringer Ingelheim Investigational Site

Seongnam, South Korea

Location

1275.9.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1275.9.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1275.9.82007 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1275.9.82008 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1275.9.82010 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1275.9.34011 Boehringer Ingelheim Investigational Site

A Coruña, Spain

Location

1275.9.34009 Boehringer Ingelheim Investigational Site

Alicante, Spain

Location

1275.9.34005 Boehringer Ingelheim Investigational Site

Badía Del Vallès - Barcelona, Spain

Location

1275.9.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1275.9.34003 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1275.9.34004 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1275.9.34002 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1275.9.34010 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1275.9.34006 Boehringer Ingelheim Investigational Site

Vic, Spain

Location

1275.9.88606 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1275.9.88607 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1275.9.88602 Boehringer Ingelheim Investigational Site

New Taipei City, Taiwan

Location

1275.9.88603 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1275.9.88604 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1275.9.88605 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 27913576 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin; empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 28, 2012
• Study Start: February 8, 2013
• Primary Completion: March 23, 2015
• Study Completion: March 23, 2015
• Last Updated: September 19, 2024
• Results First Posted: April 18, 2016

Record last verified: 2024-08

Locations

NO (5); US (28); BR (5); CA (6); FR (7); EL (1); KR (9); TW (6); NZ (8); ES (9); AU (6)