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Trial record 1 of 1 for:    NCT01422876
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Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT01422876
Recruitment Status : Completed
First Posted : August 25, 2011
Results First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 23, 2011
First Posted Date  ICMJE August 25, 2011
Results First Submitted Date  ICMJE January 15, 2015
Results First Posted Date  ICMJE April 2, 2015
Last Update Posted Date April 2, 2015
Study Start Date  ICMJE August 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2015)
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients [ Time Frame: Baseline and 24 weeks ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2011)
Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT01422876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2015)
  • Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients [ Time Frame: Baseline and 24 Weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2011)
  • Change from baseline in fasting plasma glucose [ Time Frame: 24 Weeks ]
  • Change from baseline in body weight [ Time Frame: 24 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2015)
1405
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2011)
1300
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Colombia,   Denmark,   Estonia,   Hungary,   Italy,   Lebanon,   Malaysia,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Taiwan,   United States
Removed Location Countries India,   Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT01422876
Other Study ID Numbers  ICMJE 1275.1
2011-000383-10 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date March 2015

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