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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2011-000383-10
Secondary ID [2] 0 0
1275.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients - 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.
Timepoint [1] 0 0
Baseline and 24 weeks
Primary outcome [2] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients - 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.
Timepoint [2] 0 0
Baseline and 24 weeks
Secondary outcome [1] 0 0
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 Metformin Background patients.
Timepoint [1] 0 0
Baseline and 24 Weeks
Secondary outcome [2] 0 0
Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients - Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.
Timepoint [2] 0 0
Baseline and 24 Weeks
Secondary outcome [3] 0 0
Change From Baseline in Body Weight for Metformin Background Patients - Change from baseline in body weight for Metformin Background patients.
Timepoint [3] 0 0
Baseline and 24 Weeks
Secondary outcome [4] 0 0
Change From Baseline in Body Weight for Treatment Naive Patients - Change from baseline in body weight for Treatment Naive patients.
Timepoint [4] 0 0
Baseline and 24 Weeks
Secondary outcome [5] 0 0
Occurrence of Treat to Target Efficacy Response for Metformin Background Patients - 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.
Timepoint [5] 0 0
24 Weeks
Secondary outcome [6] 0 0
Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients - 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.
Timepoint [6] 0 0
24 Weeks

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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
1275.1.61003 Boehringer Ingelheim Investigational Site - Wollongong
Recruitment hospital [2] 0 0
1275.1.61002 Boehringer Ingelheim Investigational Site - East Ringwood
Recruitment postcode(s) [1] 0 0
- Wollongong
Recruitment postcode(s) [2] 0 0
- East Ringwood
Recruitment outside Australia
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United States of America
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01422876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications