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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01778049
First received: January 24, 2013
Last updated: March 4, 2016
Last verified: March 2016

January 24, 2013
March 4, 2016
January 2013
March 2015   (final data collection date for primary outcome measure)
Change From Baseline of HbA1c After 24 Weeks of Treatment. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.

Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.

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 ]
Complete list of historical versions of study NCT01778049 on ClinicalTrials.gov Archive Site
Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.
Fasting plasma glucose (FPG) change from baseline (Visit 5) at 24 weeks (or Visit 9) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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 25/5 mg Dose FDC active
  • 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 placebo FDC
  • Drug: BI 10773 / BI 1356 Placebo
    Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
  • 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 / BI 1356 Placebo
    • Drug: BI 10773
  • 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: 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
    • Drug: BI 10773 / BI 1356 Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
708
March 2015
March 2015   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   El Salvador,   Germany,   Italy,   Portugal,   Russian Federation,   Spain,   Ukraine
India
 
NCT01778049
1275.10, 2012-002271-34
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2016

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