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

  Show 104 Study Locations
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 16, 2014