Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients 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:
NCT01734785
First received: November 16, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

This trial will compare the use of the FDC of empagliflozin and linagliptin to linagliptin alone as add-on to metformin in patients with T2DM.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Linagliptin
Drug: Empagliflozin + Linagliptin
Drug: Empaglifozin placebo + Linagliptin 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, 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • HbA1c change from baseline after 24 weeks double-blind randomized treatment [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose (FPG) change from baseline after 24 weeks of double-blind treatment. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Body weight change from baseline after 24 weeks of double-blind treatment [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]

Estimated Enrollment: 444
Study Start Date: January 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734785

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

  Hide Study Locations
Locations
United States, Alabama
1275.9.01013 Boehringer Ingelheim Investigational Site Recruiting
Gulf Shores, Alabama, United States
United States, California
1275.9.01009 Boehringer Ingelheim Investigational Site Recruiting
Norwalk, California, United States
1275.9.01015 Boehringer Ingelheim Investigational Site Recruiting
San Diego, California, United States
1275.9.01017 Boehringer Ingelheim Investigational Site Recruiting
San Diego, California, United States
United States, Colorado
1275.9.01011 Boehringer Ingelheim Investigational Site Recruiting
Northglenn, Colorado, United States
United States, Florida
1275.9.01010 Boehringer Ingelheim Investigational Site Recruiting
Coral Gables, Florida, United States
1275.9.01004 Boehringer Ingelheim Investigational Site Recruiting
Miami, Florida, United States
1275.9.01006 Boehringer Ingelheim Investigational Site Recruiting
Oldsmar, Florida, United States
1275.9.01001 Boehringer Ingelheim Investigational Site Recruiting
Palm Coast, Florida, United States
1275.9.01027 Boehringer Ingelheim Investigational Site Recruiting
Port Orange, Florida, United States
United States, Georgia
1275.9.01029 Boehringer Ingelheim Investigational Site Recruiting
Blue Ridge, Georgia, United States
1275.9.01003 Boehringer Ingelheim Investigational Site Recruiting
Marietta, Georgia, United States
1275.9.01022 Boehringer Ingelheim Investigational Site Recruiting
Savannah, Georgia, United States
United States, Illinois
1275.9.01031 Boehringer Ingelheim Investigational Site Recruiting
Chicago, Illinois, United States
United States, Massachusetts
1275.9.01026 Boehringer Ingelheim Investigational Site Recruiting
North Attleboro, Massachusetts, United States
United States, Michigan
1275.9.01008 Boehringer Ingelheim Investigational Site Recruiting
Petoskey, Michigan, United States
1275.9.01024 Boehringer Ingelheim Investigational Site Recruiting
Troy, Michigan, United States
United States, Missouri
1275.9.01023 Boehringer Ingelheim Investigational Site Recruiting
St. Louis, Missouri, United States
United States, Nebraska
1275.9.01002 Boehringer Ingelheim Investigational Site Recruiting
Omaha, Nebraska, United States
United States, New Hampshire
1275.9.01007 Boehringer Ingelheim Investigational Site Recruiting
Newington, New Hampshire, United States
United States, North Carolina
1275.9.01016 Boehringer Ingelheim Investigational Site Recruiting
Asheboro, North Carolina, United States
1275.9.01025 Boehringer Ingelheim Investigational Site Recruiting
Burlington, North Carolina, United States
1275.9.01014 Boehringer Ingelheim Investigational Site Recruiting
Shelby, North Carolina, United States
1275.9.01028 Boehringer Ingelheim Investigational Site Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
1275.9.01018 Boehringer Ingelheim Investigational Site Recruiting
Dayton, Ohio, United States
United States, Oregon
1275.9.01005 Boehringer Ingelheim Investigational Site Recruiting
Corvallis, Oregon, United States
United States, Texas
1275.9.01030 Boehringer Ingelheim Investigational Site Not yet recruiting
Houston, Texas, United States
1275.9.01021 Boehringer Ingelheim Investigational Site Recruiting
San Antonio, Texas, United States
United States, Virginia
1275.9.01020 Boehringer Ingelheim Investigational Site Recruiting
Ashburn, Virginia, United States
1275.9.01019 Boehringer Ingelheim Investigational Site Recruiting
Haverbill, Virginia, United States
Australia, New South Wales
1275.9.61009 Boehringer Ingelheim Investigational Site Recruiting
Liverpool, New South Wales, Australia
1275.9.61001 Boehringer Ingelheim Investigational Site Recruiting
St Leonards, New South Wales, Australia
Australia, Queensland
1275.9.61003 Boehringer Ingelheim Investigational Site Terminated
Carina Heights, Queensland, Australia
1275.9.61002 Boehringer Ingelheim Investigational Site Recruiting
Herston, Queensland, Australia
Australia, Victoria
1275.9.61006 Boehringer Ingelheim Investigational Site Terminated
Malvern, Victoria, Australia
Australia, Western Australia
1275.9.61007 Boehringer Ingelheim Investigational Site Terminated
Nedlands, Western Australia, Australia
Brazil
1275.9.55002 Boehringer Ingelheim Investigational Site Recruiting
Brasilia, Brazil
1275.9.55005 Boehringer Ingelheim Investigational Site Recruiting
Goiania, Brazil
1275.9.55001 Boehringer Ingelheim Investigational Site Recruiting
Sao Paulo, Brazil
1275.9.55003 Boehringer Ingelheim Investigational Site Recruiting
Sao Paulo, Brazil
1275.9.55004 Boehringer Ingelheim Investigational Site Recruiting
Sao Paulo, Brazil
Canada, British Columbia
1275.9.01101 Boehringer Ingelheim Investigational Site Not yet recruiting
Burnaby, British Columbia, Canada
1275.9.01103 Boehringer Ingelheim Investigational Site Not yet recruiting
Victoria, British Columbia, Canada
Canada, Ontario
1275.9.01105 Boehringer Ingelheim Investigational Site Not yet recruiting
Cornwall, Ontario, Canada
1275.9.01106 Boehringer Ingelheim Investigational Site Not yet recruiting
Hamilton, Ontario, Canada
1275.9.01102 Boehringer Ingelheim Investigational Site Not yet recruiting
Kitchener, Ontario, Canada
1275.9.01104 Boehringer Ingelheim Investigational Site Not yet recruiting
Toronto, Ontario, Canada
El Salvador
1275.9.34008 Boehringer Ingelheim Investigational Site Recruiting
Barcelona, El Salvador
France
1275.9.33006 Boehringer Ingelheim Investigational Site Recruiting
Bourg des Comptes, France
1275.9.33007 Boehringer Ingelheim Investigational Site Recruiting
Colmar, France
1275.9.33011 Boehringer Ingelheim Investigational Site Recruiting
Derval, France
1275.9.33008 Boehringer Ingelheim Investigational Site Completed
Dessenheim, France
1275.9.33003 Boehringer Ingelheim Investigational Site Recruiting
La Riche, France
1275.9.33010 Boehringer Ingelheim Investigational Site Recruiting
Louvigne De Bais, France
1275.9.33012 Boehringer Ingelheim Investigational Site Not yet recruiting
Paris, France
1275.9.33009 Boehringer Ingelheim Investigational Site Recruiting
Riedisheim, France
1275.9.33002 Boehringer Ingelheim Investigational Site Recruiting
Saint Avertin, France
1275.9.33005 Boehringer Ingelheim Investigational Site Completed
Savonnieres, France
1275.9.33004 Boehringer Ingelheim Investigational Site Recruiting
Tours, France
1275.9.33001 Boehringer Ingelheim Investigational Site Recruiting
Tours, France
Italy
1275.9.39002 Boehringer Ingelheim Investigational Site Not yet recruiting
Catania, Italy
1275.9.39001 Boehringer Ingelheim Investigational Site Not yet recruiting
Milano, Italy
1275.9.39003 Boehringer Ingelheim Investigational Site Not yet recruiting
Terni, Italy
Korea, Republic of
1275.9.82006 Boehringer Ingelheim Investigational Site Recruiting
Daejeon, Korea, Republic of
1275.9.82009 Boehringer Ingelheim Investigational Site Recruiting
Deagu, Korea, Republic of
1275.9.82002 Boehringer Ingelheim Investigational Site Recruiting
Goyang, Korea, Republic of
1275.9.82004 Boehringer Ingelheim Investigational Site Recruiting
Seongnam, Korea, Republic of
1275.9.82005 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1275.9.82001 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1275.9.82010 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1275.9.82008 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1275.9.82007 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1275.9.82003 Boehringer Ingelheim Investigational Site Recruiting
Uijeongbu, Korea, Republic of
New Zealand
1275.9.64006 Boehringer Ingelheim Investigational Site Recruiting
Auckland, New Zealand, New Zealand
1275.9.64005 Boehringer Ingelheim Investigational Site Recruiting
Auckland, New Zealand, New Zealand
1275.9.64008 Boehringer Ingelheim Investigational Site Recruiting
Birkenhead Auckland, New Zealand
1275.9.64004 Boehringer Ingelheim Investigational Site Recruiting
Christchurch, New Zealand, New Zealand
1275.9.64002 Boehringer Ingelheim Investigational Site Recruiting
Otahuhu Auckland, New Zealand
1275.9.64007 Boehringer Ingelheim Investigational Site Recruiting
Shirley Christchurch, New Zealand
1275.9.64001 Boehringer Ingelheim Investigational Site Recruiting
Takapuna Auckland, New Zealand
1275.9.64003 Boehringer Ingelheim Investigational Site Recruiting
Tauranga, New Zealand, New Zealand
Norway
1275.9.47001 Boehringer Ingelheim Investigational Site Recruiting
Bergen, Norway
1275.9.47007 Boehringer Ingelheim Investigational Site Recruiting
Oslo, Norway
1275.9.47003 Boehringer Ingelheim Investigational Site Recruiting
Oslo, Norway
1275.9.47002 Boehringer Ingelheim Investigational Site Recruiting
Oslo, Norway
1275.9.47006 Boehringer Ingelheim Investigational Site Recruiting
Svelvik, Norway
Spain
1275.9.34011 Boehringer Ingelheim Investigational Site Recruiting
A Coruña, Spain
1275.9.34009 Boehringer Ingelheim Investigational Site Recruiting
Alicante, Spain
1275.9.34005 Boehringer Ingelheim Investigational Site Recruiting
Badía del Vallès - Barcelona, Spain
1275.9.34004 Boehringer Ingelheim Investigational Site Recruiting
Barcelona, Spain
1275.9.34001 Boehringer Ingelheim Investigational Site Recruiting
Barcelona, Spain
1275.9.34003 Boehringer Ingelheim Investigational Site Recruiting
Barcelona, Spain
1275.9.34012 Boehringer Ingelheim Investigational Site Recruiting
Borges del Camp, Spain
1275.9.34002 Boehringer Ingelheim Investigational Site Recruiting
Sevilla, Spain
1275.9.34010 Boehringer Ingelheim Investigational Site Recruiting
Valencia, Spain
1275.9.34006 Boehringer Ingelheim Investigational Site Recruiting
Vic, Spain
Taiwan
1275.9.88607 Boehringer Ingelheim Investigational Site Recruiting
Kaohsiung, Taiwan
1275.9.88606 Boehringer Ingelheim Investigational Site Recruiting
Kaohsiung, Taiwan
1275.9.88602 Boehringer Ingelheim Investigational Site Recruiting
New Taipei, Taiwan
1275.9.88603 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1275.9.88604 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1275.9.88605 Boehringer Ingelheim Investigational Site Recruiting
Tainan, Taiwan
1275.9.88608 Boehringer Ingelheim Investigational Site Recruiting
Taipei, Taiwan
1275.9.88601 Boehringer Ingelheim Investigational Site Recruiting
Taipei, Taiwan
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: NCT01734785     History of Changes
Other Study ID Numbers: 1275.9, 2012-002270-31
Study First Received: November 16, 2012
Last Updated: April 16, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
France: Agence Nationale sécurité médicament et des produits santé
Italy: The Italian Medicines Agency
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Romania: National Medicines Agency
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014