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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 June 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01778049
First received: January 24, 2013
Last updated: June 13, 2013
Last verified: June 2013
History of Changes

January 24, 2013
June 13, 2013
January 2013
August 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01778049 on ClinicalTrials.gov Archive Site
Fasting plasma glucose (FPG) change from baseline (Visit 5) at 24 weeks (or Visit 9) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: BI 10773
    Empagliflozin active
  • Drug: BI 10773 Placebo
    Empagliflozin placebo
  • Drug: BI 10773 / BI 1356
    Empagliflozin / Linagliptin 10/5 mg Dose FDC active
  • Drug: BI 10773 / BI 1356 Placebo
    Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
  • Experimental: Empagliflozin 10 mg dose
    Empagliflozin open label treatment period
    Intervention: Drug: BI 10773
  • Experimental: Placebo add on 10 mg dose
    Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
    Interventions:
    • Drug: BI 10773
    • Drug: BI 10773 / BI 1356 Placebo
  • Experimental: Empagliflozin/Linagliptin 25/5 mg Dose
    Empagliflozin / Linagliptin 25/5 mg Dose FDC active
    Interventions:
    • Drug: BI 10773 / BI 1356
    • Drug: BI 10773 Placebo
  • Experimental: Empagliflozin/Linagliptin 10/5 mg Dose.
    Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
    Interventions:
    • Drug: BI 10773 / BI 1356 Placebo
    • Drug: BI 10773
  • Experimental: Empagliflozin/Linagliptin 10/5 mg Dose
    Empagliflozin / Linagliptin 10/5 mg Dose FDC active
    Interventions:
    • Drug: BI 10773 Placebo
    • Drug: BI 10773 / BI 1356
  • Experimental: Placebo add on 25 mg dose
    Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
    Interventions:
    • Drug: BI 10773
    • Drug: BI 10773 / BI 1356 Placebo
  • Experimental: Empagliflozin 25 mg dose
    Empagliflozin open label treatment period
    Intervention: Drug: BI 10773
  • Experimental: Empagliflozin/Linagliptin 25/5 mg Dose.
    Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
    Interventions:
    • Drug: BI 10773 / BI 1356 Placebo
    • Drug: BI 10773
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
690
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States,   Argentina,   Australia,   Canada,   El Salvador,   Germany,   Italy,   Portugal,   Russian Federation,   Spain,   Ukraine
 
NCT01778049
1275.10, 2012-002271-34
Not Provided
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP