Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01422876
First received: August 23, 2011
Last updated: April 1, 2015
Last verified: March 2015

August 23, 2011
April 1, 2015
August 2011
September 2013   (final data collection date for primary outcome measure)
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01422876 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.
  • Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.
  • Change From Baseline in Body Weight for Metformin Background Patients [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in body weight for Metformin Background patients.
  • Change From Baseline in Body Weight for Treatment Naive Patients [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in body weight for Treatment Naive patients.
  • Occurrence of Treat to Target Efficacy Response for Metformin Background Patients [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.
  • Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.
  • Change from baseline in fasting plasma glucose [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

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: high dose FDC
    once daily
  • Drug: BI 10773 high dose
    once daily
  • Drug: high dose FDC placebo
    once daily
  • Drug: low dose FDC placebo
    once daily
  • Drug: high dose BI 10773 placebo
    once daily
  • Drug: low dose FDC
    once daily
  • Drug: BI 10773 low dose
    low dose once daily
  • Drug: linagliptin
    once daily
  • Drug: linagliptin placebo
    once daily
  • Drug: BI 10773 low dose placebo
    once daily
  • Drug: low dose BI 10773 placebo
    once daily
  • Experimental: BI 10773/linagliptin FDC (high dose)
    Patients receive BI 10773/linagliptin FDC (high dose) once daily
    Interventions:
    • Drug: high dose FDC
    • Drug: low dose FDC placebo
    • Drug: high dose BI 10773 placebo
    • Drug: BI 10773 low dose placebo
    • Drug: linagliptin placebo
  • Experimental: BI 10773/linagliptin FDC (low dose)
    Patients receive BI 10773/linagliptin FDC (low dose) once daily
    Interventions:
    • Drug: high dose FDC placebo
    • Drug: low dose FDC
    • Drug: high dose BI 10773 placebo
    • Drug: BI 10773 low dose placebo
    • Drug: linagliptin placebo
  • Active Comparator: BI 10773 (high dose)
    Patients receive BI 10773 (high dose) once daily
    Interventions:
    • Drug: BI 10773 high dose
    • Drug: high dose FDC placebo
    • Drug: low dose FDC placebo
    • Drug: low dose BI 10773 placebo
    • Drug: linagliptin placebo
  • Active Comparator: BI 10773 (low dose)
    Patients receive BI 10773 (low dose) once daily
    Interventions:
    • Drug: high dose FDC placebo
    • Drug: low dose FDC placebo
    • Drug: high dose BI 10773 placebo
    • Drug: BI 10773 low dose
    • Drug: linagliptin placebo
  • Active Comparator: Linagliptin
    Patients receive linagliptin once daily
    Interventions:
    • Drug: low dose FDC placebo
    • Drug: high dose FDC placebo
    • Drug: linagliptin
    • Drug: high dose BI 10773 placebo
    • Drug: low dose BI 10773 placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1405
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
  3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Exclusion criteria:

  1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
  2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
  3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Colombia,   Denmark,   Estonia,   Hungary,   Italy,   Lebanon,   Malaysia,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Taiwan
Korea, Republic of,   India
 
NCT01422876
1275.1, 2011-000383-10
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2015

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