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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01422876
Registration number
NCT01422876
Ethics application status
Date submitted
23/08/2011
Date registered
25/08/2011
Date last updated
2/04/2015
Titles & IDs
Public title
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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Scientific title
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
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Secondary ID [1]
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2011-000383-10
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Secondary ID [2]
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1275.1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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0
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Condition category
Condition code
Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - high dose FDC
Treatment: Drugs - BI 10773 high dose
Treatment: Drugs - high dose FDC placebo
Treatment: Drugs - low dose FDC placebo
Treatment: Drugs - high dose FDC placebo
Treatment: Drugs - high dose FDC placebo
Treatment: Drugs - low dose FDC placebo
Treatment: Drugs - low dose FDC placebo
Treatment: Drugs - high dose BI 10773 placebo
Treatment: Drugs - low dose FDC
Treatment: Drugs - high dose FDC placebo
Treatment: Drugs - BI 10773 low dose
Treatment: Drugs - high dose BI 10773 placebo
Treatment: Drugs - high dose BI 10773 placebo
Treatment: Drugs - linagliptin
Treatment: Drugs - low dose FDC placebo
Treatment: Drugs - linagliptin placebo
Treatment: Drugs - BI 10773 low dose placebo
Treatment: Drugs - linagliptin placebo
Treatment: Drugs - low dose BI 10773 placebo
Treatment: Drugs - linagliptin placebo
Treatment: Drugs - high dose BI 10773 placebo
Treatment: Drugs - BI 10773 low dose placebo
Treatment: Drugs - low dose BI 10773 placebo
Treatment: Drugs - linagliptin placebo
Experimental: BI 10773/linagliptin FDC (high dose) - Patients receive BI 10773/linagliptin FDC (high dose) once daily
Experimental: BI 10773/linagliptin FDC (low dose) - Patients receive BI 10773/linagliptin FDC (low dose) once daily
Active comparator: BI 10773 (high dose) - Patients receive BI 10773 (high dose) once daily
Active comparator: BI 10773 (low dose) - Patients receive BI 10773 (low dose) once daily
Active comparator: Linagliptin - Patients receive linagliptin once daily
Treatment: Drugs: high dose FDC
once daily
Treatment: Drugs: BI 10773 high dose
once daily
Treatment: Drugs: high dose FDC placebo
once daily
Treatment: Drugs: low dose FDC placebo
once daily
Treatment: Drugs: high dose FDC placebo
once daily
Treatment: Drugs: high dose FDC placebo
once daily
Treatment: Drugs: low dose FDC placebo
once daily
Treatment: Drugs: low dose FDC placebo
once daily
Treatment: Drugs: high dose BI 10773 placebo
once daily
Treatment: Drugs: low dose FDC
once daily
Treatment: Drugs: high dose FDC placebo
once daily
Treatment: Drugs: BI 10773 low dose
low dose once daily
Treatment: Drugs: high dose BI 10773 placebo
once daily
Treatment: Drugs: high dose BI 10773 placebo
once daily
Treatment: Drugs: linagliptin
once daily
Treatment: Drugs: low dose FDC placebo
once daily
Treatment: Drugs: linagliptin placebo
once daily
Treatment: Drugs: BI 10773 low dose placebo
once daily
Treatment: Drugs: linagliptin placebo
once daily
Treatment: Drugs: low dose BI 10773 placebo
once daily
Treatment: Drugs: linagliptin placebo
once daily
Treatment: Drugs: high dose BI 10773 placebo
once daily
Treatment: Drugs: BI 10773 low dose placebo
once daily
Treatment: Drugs: low dose BI 10773 placebo
once daily
Treatment: Drugs: linagliptin placebo
once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and 24 weeks
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Primary outcome [2]
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and 24 weeks
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Secondary outcome [1]
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Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients
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Assessment method [1]
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Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.
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Timepoint [1]
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Baseline and 24 Weeks
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Secondary outcome [2]
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Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients
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Assessment method [2]
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Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.
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Timepoint [2]
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Baseline and 24 Weeks
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Secondary outcome [3]
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Change From Baseline in Body Weight for Metformin Background Patients
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Assessment method [3]
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Change from baseline in body weight for Metformin Background patients.
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Timepoint [3]
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Baseline and 24 Weeks
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Secondary outcome [4]
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Change From Baseline in Body Weight for Treatment Naive Patients
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Assessment method [4]
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Change from baseline in body weight for Treatment Naive patients.
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Timepoint [4]
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Baseline and 24 Weeks
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Secondary outcome [5]
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Occurrence of Treat to Target Efficacy Response for Metformin Background Patients
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Assessment method [5]
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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.
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Timepoint [5]
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24 Weeks
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Secondary outcome [6]
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Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients
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Assessment method [6]
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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.
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Timepoint [6]
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24 Weeks
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Eligibility
Key inclusion criteria
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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2013
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Sample size
Target
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Accrual to date
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Final
1405
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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1275.1.61003 Boehringer Ingelheim Investigational Site - Wollongong
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Recruitment hospital [2]
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1275.1.61002 Boehringer Ingelheim Investigational Site - East Ringwood
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Recruitment postcode(s) [1]
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- Wollongong
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Recruitment postcode(s) [2]
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- East Ringwood
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Recruitment outside Australia
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Alabama
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Massachusetts
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Other collaborator category [1]
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Commercial sector/industry
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Eli Lilly and Company
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01422876
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Trial related presentations / publications
DeFronzo RA, Lee C, Kohler S. Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials. Adv Ther. 2018 Jul;35(7):1009-1022. doi: 10.1007/s12325-018-0724-y. Epub 2018 Jun 15. Lewin A, DeFronzo RA, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):394-402. doi: 10.2337/dc14-2365. Epub 2015 Jan 29. Erratum In: Diabetes Care. 2015 Jun;38(6):1173. doi: 10.2337/dc15-er06a. DeFronzo RA, Lewin A, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015 Mar;38(3):384-93. doi: 10.2337/dc14-2364. Epub 2015 Jan 12. Erratum In: Diabetes Care. 2015 Jun;38(6):1173. doi: 10.2337/dc15-er06.
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01422876
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