Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01778049
First received: January 24, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773
Drug: BI 10773 Placebo
Drug: BI 10773 / BI 1356
Drug: BI 10773 / BI 1356 Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change of HbA1c after 24 weeks of treatment (at week 24 or Visit 9) from baseline (Visit 5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose (FPG) change from baseline (Visit 5) at 24 weeks (or Visit 9) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 681
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Empagliflozin 10 mg dose
Empagliflozin open label treatment period
Drug: BI 10773
Empagliflozin active
Experimental: Placebo add on 10 mg dose
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
Drug: BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC
Drug: BI 10773
Empagliflozin active
Experimental: Empagliflozin/Linagliptin 25/5 mg Dose
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Drug: BI 10773 / BI 1356
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Drug: BI 10773 Placebo
Empagliflozin placebo
Experimental: Empagliflozin/Linagliptin 10/5 mg Dose.
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Drug: BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Drug: BI 10773
Empagliflozin active
Experimental: Empagliflozin/Linagliptin 10/5 mg Dose
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Drug: BI 10773 Placebo
Empagliflozin placebo
Drug: BI 10773 / BI 1356
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Experimental: Placebo add on 25 mg dose
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
Drug: BI 10773
Empagliflozin active
Drug: BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Experimental: Empagliflozin 25 mg dose
Empagliflozin open label treatment period
Drug: BI 10773
Empagliflozin active
Experimental: Empagliflozin/Linagliptin 25/5 mg Dose.
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Drug: BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Drug: BI 10773
Empagliflozin active

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Signed and dated ICF (Informed Consent Form)
  2. Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label
  3. HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1
  4. HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4
  5. Age > or equal to 18 years
  6. BMI (Body Mass Index) < or equal to 45

Exclusion criteria:

  1. Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
  2. Use of any other antidiabetic
  3. Renal function below 60 ml/min/1.73 m2
  4. Antiobesity drugs or aggresive diets
  5. Gastorintestinal surgeries
  6. Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
  7. Acute coronary syndrome and stroke within 3 months of informed consent
  8. Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778049

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
United States, California
1275.10.01019 Boehringer Ingelheim Investigational Site Recruiting
Chino, California, United States
1275.10.01008 Boehringer Ingelheim Investigational Site Recruiting
Huntington Beach, California, United States
1275.10.01003 Boehringer Ingelheim Investigational Site Recruiting
San Diego, California, United States
1275.10.01024 Boehringer Ingelheim Investigational Site Recruiting
San Diego, California, United States
1275.10.01002 Boehringer Ingelheim Investigational Site Recruiting
Sylmar, California, United States
United States, Florida
1275.10.01011 Boehringer Ingelheim Investigational Site Recruiting
Miami, Florida, United States
1275.10.01009 Boehringer Ingelheim Investigational Site Recruiting
Orlando, Florida, United States
1275.10.01023 Boehringer Ingelheim Investigational Site Recruiting
Oviedo, Florida, United States
1275.10.01006 Boehringer Ingelheim Investigational Site Terminated
Tamarac, Florida, United States
United States, Georgia
1275.10.01017 Boehringer Ingelheim Investigational Site Recruiting
Conyers, Georgia, United States
1275.10.01016 Boehringer Ingelheim Investigational Site Recruiting
Snellville, Georgia, United States
United States, Indiana
1275.10.01012 Boehringer Ingelheim Investigational Site Recruiting
Avon, Indiana, United States
1275.10.01013 Boehringer Ingelheim Investigational Site Recruiting
Muncie, Indiana, United States
United States, Maryland
1275.10.01010 Boehringer Ingelheim Investigational Site Recruiting
Elkton, Maryland, United States
United States, Michigan
1275.10.01001 Boehringer Ingelheim Investigational Site Recruiting
Stevensville, Michigan, United States
United States, North Carolina
1275.10.01007 Boehringer Ingelheim Investigational Site Recruiting
Salisbury, North Carolina, United States
United States, North Dakota
1275.10.01005 Boehringer Ingelheim Investigational Site Terminated
Bismarck, North Dakota, United States
United States, Oklahoma
1275.10.01020 Boehringer Ingelheim Investigational Site Recruiting
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
1275.10.01022 Boehringer Ingelheim Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States
United States, South Carolina
1275.10.01021 Boehringer Ingelheim Investigational Site Recruiting
Union, South Carolina, United States
United States, Texas
1275.10.01014 Boehringer Ingelheim Investigational Site Recruiting
North Richland Hills, Texas, United States
United States, Utah
1275.10.01018 Boehringer Ingelheim Investigational Site Recruiting
Draper, Utah, United States
United States, Virginia
1275.10.01015 Boehringer Ingelheim Investigational Site Recruiting
Richmond, Virginia, United States
1275.10.01025 Boehringer Ingelheim Investigational Site Recruiting
Virginia Beach, Virginia, United States
Argentina
1275.10.54005 Boehringer Ingelheim Investigational Site Recruiting
Caba, Argentina
1275.10.54012 Boehringer Ingelheim Investigational Site Recruiting
Caba, Argentina
1275.10.54002 Boehringer Ingelheim Investigational Site Recruiting
Capital Federal, Argentina
1275.10.54007 Boehringer Ingelheim Investigational Site Recruiting
Capital Federal, Argentina
1275.10.54013 Boehringer Ingelheim Investigational Site Recruiting
Capital Federal, Argentina
1275.10.54006 Boehringer Ingelheim Investigational Site Recruiting
Cordoba, Argentina
1275.10.54008 Boehringer Ingelheim Investigational Site Recruiting
Cordoba, Argentina
1275.10.54011 Boehringer Ingelheim Investigational Site Recruiting
Córdoba, Argentina
1275.10.54009 Boehringer Ingelheim Investigational Site Recruiting
Mar del Plata, Argentina
1275.10.54003 Boehringer Ingelheim Investigational Site Recruiting
Mendoza, Argentina
1275.10.54004 Boehringer Ingelheim Investigational Site Recruiting
Salta, Argentina
1275.10.54001 Boehringer Ingelheim Investigational Site Recruiting
San Isidro, Argentina
1275.10.54010 Boehringer Ingelheim Investigational Site Recruiting
Zarate, Argentina
Australia, New South Wales
1275.10.61008 Boehringer Ingelheim Investigational Site Recruiting
Cardiff, New South Wales, Australia
Australia, Victoria
1275.10.61002 Boehringer Ingelheim Investigational Site Recruiting
East Ringwood, Victoria, Australia
1275.10.61001 Boehringer Ingelheim Investigational Site Recruiting
Heidelberg Heights, Victoria, Australia
Australia, Western Australia
1275.10.61009 Boehringer Ingelheim Investigational Site Recruiting
Mirrabooka, Western Australia, Australia
Canada, Alberta
1275.10.02004 Boehringer Ingelheim Investigational Site Recruiting
Edmonton, Alberta, Canada
1275.10.02001 Boehringer Ingelheim Investigational Site Recruiting
Red Deer, Alberta, Canada
Canada, British Columbia
1275.10.02003 Boehringer Ingelheim Investigational Site Recruiting
Chilliwack, British Columbia, Canada
1275.10.02009 Boehringer Ingelheim Investigational Site Recruiting
Coquitlam, British Columbia, Canada
1275.10.02012 Boehringer Ingelheim Investigational Site Recruiting
Vancouver, British Columbia, Canada
Canada, Manitoba
1275.10.02006 Boehringer Ingelheim Investigational Site Recruiting
Winnipeg, Manitoba, Canada
1275.10.02008 Boehringer Ingelheim Investigational Site Recruiting
Winnipeg, Manitoba, Canada
Canada, New Brunswick
1275.10.02005 Boehringer Ingelheim Investigational Site Recruiting
Moncton, New Brunswick, Canada
Canada, Ontario
1275.10.02013 Boehringer Ingelheim Investigational Site Recruiting
Burlington, Ontario, Canada
1275.10.02002 Boehringer Ingelheim Investigational Site Recruiting
Strathroy, Ontario, Canada
1275.10.02007 Boehringer Ingelheim Investigational Site Recruiting
Sudbury, Ontario, Canada
Canada, Quebec
1275.10.02011 Boehringer Ingelheim Investigational Site Recruiting
Drummondville, Quebec, Canada
1275.10.02010 Boehringer Ingelheim Investigational Site Recruiting
Montreal, Quebec, Canada
El Salvador
1275.10.34014 Boehringer Ingelheim Investigational Site Recruiting
Ávila, El Salvador
Germany
1275.10.49007 Boehringer Ingelheim Investigational Site Recruiting
Asslar, Germany
1275.10.49014 Boehringer Ingelheim Investigational Site Recruiting
Berlin, Germany
1275.10.49016 Boehringer Ingelheim Investigational Site Recruiting
Elsterwerda, Germany
1275.10.49012 Boehringer Ingelheim Investigational Site Recruiting
Hamburg, Germany
1275.10.49005 Boehringer Ingelheim Investigational Site Recruiting
Hatten, Germany
1275.10.49008 Boehringer Ingelheim Investigational Site Recruiting
Kiel Kronshagen, Germany
1275.10.49004 Boehringer Ingelheim Investigational Site Active, not recruiting
Köln, Germany
1275.10.49010 Boehringer Ingelheim Investigational Site Recruiting
Lübeck, Germany
1275.10.49003 Boehringer Ingelheim Investigational Site Recruiting
Münster, Germany
1275.10.49006 Boehringer Ingelheim Investigational Site Recruiting
Pirna, Germany
1275.10.49013 Boehringer Ingelheim Investigational Site Recruiting
St. Ingbert/Oberwürzbach, Germany
1275.10.49001 Boehringer Ingelheim Investigational Site Recruiting
Unterschneidheim, Germany
1275.10.49015 Boehringer Ingelheim Investigational Site Recruiting
Wangen, Germany
Italy
1275.10.39005 Boehringer Ingelheim Investigational Site Recruiting
Ancona, Italy
1275.10.39014 Boehringer Ingelheim Investigational Site Recruiting
Catania, Italy
1275.10.39009 Boehringer Ingelheim Investigational Site Recruiting
Catania, Italy
1275.10.39006 Boehringer Ingelheim Investigational Site Recruiting
Catania, Italy
1275.10.39007 Boehringer Ingelheim Investigational Site Recruiting
Latina, Italy
1275.10.39012 Boehringer Ingelheim Investigational Site Recruiting
Milano, Italy
1275.10.39013 Boehringer Ingelheim Investigational Site Recruiting
Milano, Italy
1275.10.39002 Boehringer Ingelheim Investigational Site Recruiting
Novara, Italy
1275.10.39015 Boehringer Ingelheim Investigational Site Recruiting
Olbia (OT), Italy
1275.10.39016 Boehringer Ingelheim Investigational Site Recruiting
Orbassano (TO), Italy
1275.10.39004 Boehringer Ingelheim Investigational Site Recruiting
Palermo, Italy
1275.10.39003 Boehringer Ingelheim Investigational Site Recruiting
Pistoia, Italy
1275.10.39008 Boehringer Ingelheim Investigational Site Recruiting
Roma, Italy
1275.10.39001 Boehringer Ingelheim Investigational Site Recruiting
Sesto San Giovanni (MI), Italy
1275.10.39010 Boehringer Ingelheim Investigational Site Recruiting
Siena, Italy
1275.10.39011 Boehringer Ingelheim Investigational Site Recruiting
Terni, Italy
Portugal
1275.10.35113 Boehringer Ingelheim Investigational Site Not yet recruiting
Amora, Portugal
1275.10.35104 Boehringer Ingelheim Investigational Site Recruiting
Cantanhede, Portugal
1275.10.35102 Boehringer Ingelheim Investigational Site Not yet recruiting
Espinho, Portugal
1275.10.35109 Boehringer Ingelheim Investigational Site Not yet recruiting
Figueira da Foz, Portugal
1275.10.35114 Boehringer Ingelheim Investigational Site Not yet recruiting
Figueira da Foz, Portugal
1275.10.35111 Boehringer Ingelheim Investigational Site Not yet recruiting
Lousã, Portugal
1275.10.35107 Boehringer Ingelheim Investigational Site Recruiting
Oeiras, Portugal
1275.10.35112 Boehringer Ingelheim Investigational Site Recruiting
Porto, Portugal
1275.10.35115 Boehringer Ingelheim Investigational Site Not yet recruiting
Porto, Portugal
1275.10.35103 Boehringer Ingelheim Investigational Site Recruiting
Sandim, Portugal
1275.10.35105 Boehringer Ingelheim Investigational Site Recruiting
Tornada, Portugal
1275.10.35108 Boehringer Ingelheim Investigational Site Recruiting
Valadares, Portugal
1275.10.35101 Boehringer Ingelheim Investigational Site Recruiting
Vila Nova de Gaia, Portugal
Russian Federation
1275.10.07004 Boehringer Ingelheim Investigational Site Recruiting
Chelyabinsk, Russian Federation
1275.10.07006 Boehringer Ingelheim Investigational Site Recruiting
Saint-Petersburg, Russian Federation
1275.10.07001 Boehringer Ingelheim Investigational Site Recruiting
Saratov, Russian Federation
1275.10.07005 Boehringer Ingelheim Investigational Site Recruiting
Saratov, Russian Federation
1275.10.07003 Boehringer Ingelheim Investigational Site Recruiting
St. Petersburg, Russian Federation
1275.10.07002 Boehringer Ingelheim Investigational Site Recruiting
Yaroslavl, Russian Federation
Spain
1275.10.34003 Boehringer Ingelheim Investigational Site Recruiting
Barcelona, Spain
1275.10.34004 Boehringer Ingelheim Investigational Site Recruiting
Canet de Mar, Spain
1275.10.34008 Boehringer Ingelheim Investigational Site Recruiting
Centelles, Spain
1275.10.34009 Boehringer Ingelheim Investigational Site Recruiting
L'Hospitalet de Llobregat (Barcelona), Spain
1275.10.34012 Boehringer Ingelheim Investigational Site Recruiting
La Roca del Vallès, Spain
1275.10.34006 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1275.10.34010 Boehringer Ingelheim Investigational Site Recruiting
Malaga, Spain
1275.10.34011 Boehringer Ingelheim Investigational Site Recruiting
Mataró, Spain
1275.10.34001 Boehringer Ingelheim Investigational Site Recruiting
Málaga, Spain
1275.10.34013 Boehringer Ingelheim Investigational Site Recruiting
Pineda de Mar, Spain
1275.10.34002 Boehringer Ingelheim Investigational Site Recruiting
Sabadell, Spain
1275.10.34005 Boehringer Ingelheim Investigational Site Recruiting
Tarragona, Spain
Ukraine
1275.10.38006 Boehringer Ingelheim Investigational Site Recruiting
Chernivtsi, Ukraine
1275.10.38007 Boehringer Ingelheim Investigational Site Recruiting
Dnipropetrovs'k, Ukraine
1275.10.38003 Boehringer Ingelheim Investigational Site Recruiting
Kiev, Ukraine
1275.10.38002 Boehringer Ingelheim Investigational Site Recruiting
Kiev, Ukraine
1275.10.38004 Boehringer Ingelheim Investigational Site Recruiting
Lviv, Ukraine
1275.10.38001 Boehringer Ingelheim Investigational Site Recruiting
Vinnitsa, Ukraine
1275.10.38005 Boehringer Ingelheim Investigational Site Recruiting
Zhytomyr, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01778049     History of Changes
Other Study ID Numbers: 1275.10, 2012-002271-34
Study First Received: January 24, 2013
Last Updated: April 2, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Canada: Canadian Institutes of Health Research
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
BI 1356
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014