Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Timepoint [1] 0 0
Baseline and 24 weeks
Primary outcome [2] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients
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
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
Timepoint [2] 0 0
Baseline and 24 Weeks
Secondary outcome [3] 0 0
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
Timepoint [4] 0 0
Baseline and 24 Weeks
Secondary outcome [5] 0 0
Occurrence of Treat to Target Efficacy Response for Metformin Background Patients
Timepoint [5] 0 0
24 Weeks
Secondary outcome [6] 0 0
Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients
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
Sex
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
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
1405
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
Argentina
State/province [32] 0 0
Caba
Country [33] 0 0
Argentina
State/province [33] 0 0
Capital Federal
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Mar del Plata
Country [36] 0 0
Argentina
State/province [36] 0 0
Mendoza
Country [37] 0 0
Brazil
State/province [37] 0 0
Joaquim Távora
Country [38] 0 0
Brazil
State/province [38] 0 0
Rio de Janeiro - RJ
Country [39] 0 0
Brazil
State/province [39] 0 0
Sao Paulo
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Plovdiv
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Ruse
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Sofia
Country [43] 0 0
Canada
State/province [43] 0 0
New Brunswick
Country [44] 0 0
Canada
State/province [44] 0 0
Newfoundland and Labrador
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
Colombia
State/province [47] 0 0
Barranquilla
Country [48] 0 0
Colombia
State/province [48] 0 0
Bogota
Country [49] 0 0
Colombia
State/province [49] 0 0
Bogotá
Country [50] 0 0
Colombia
State/province [50] 0 0
Tolima
Country [51] 0 0
Denmark
State/province [51] 0 0
Aalborg
Country [52] 0 0
Denmark
State/province [52] 0 0
Aarhus C
Country [53] 0 0
Denmark
State/province [53] 0 0
København NV
Country [54] 0 0
Estonia
State/province [54] 0 0
Kivioli
Country [55] 0 0
Estonia
State/province [55] 0 0
Pärnu
Country [56] 0 0
Estonia
State/province [56] 0 0
Tallinn
Country [57] 0 0
Estonia
State/province [57] 0 0
Viljandi County
Country [58] 0 0
Hungary
State/province [58] 0 0
Budapest
Country [59] 0 0
Hungary
State/province [59] 0 0
Gyongyos
Country [60] 0 0
Italy
State/province [60] 0 0
Bassano del Grappa (VI)
Country [61] 0 0
Italy
State/province [61] 0 0
Fermo
Country [62] 0 0
Italy
State/province [62] 0 0
Milan
Country [63] 0 0
Italy
State/province [63] 0 0
Roma
Country [64] 0 0
Lebanon
State/province [64] 0 0
Baabda
Country [65] 0 0
Lebanon
State/province [65] 0 0
Beirut
Country [66] 0 0
Lebanon
State/province [66] 0 0
Saida
Country [67] 0 0
Malaysia
State/province [67] 0 0
Kedah
Country [68] 0 0
Malaysia
State/province [68] 0 0
Perak
Country [69] 0 0
Mexico
State/province [69] 0 0
Mexico
Country [70] 0 0
Mexico
State/province [70] 0 0
Monterrey
Country [71] 0 0
Mexico
State/province [71] 0 0
Pachuca
Country [72] 0 0
Mexico
State/province [72] 0 0
San Luis Potosí
Country [73] 0 0
Peru
State/province [73] 0 0
Arequipa
Country [74] 0 0
Peru
State/province [74] 0 0
Ica
Country [75] 0 0
Peru
State/province [75] 0 0
Lima
Country [76] 0 0
Philippines
State/province [76] 0 0
Davao
Country [77] 0 0
Philippines
State/province [77] 0 0
Greenhills, San Juan
Country [78] 0 0
Philippines
State/province [78] 0 0
Manila
Country [79] 0 0
Philippines
State/province [79] 0 0
Marikina city
Country [80] 0 0
Philippines
State/province [80] 0 0
Pasay City
Country [81] 0 0
Philippines
State/province [81] 0 0
Pasig
Country [82] 0 0
Poland
State/province [82] 0 0
Lodz
Country [83] 0 0
Poland
State/province [83] 0 0
Poznan
Country [84] 0 0
Poland
State/province [84] 0 0
Warsaw
Country [85] 0 0
Romania
State/province [85] 0 0
Alba Iulia
Country [86] 0 0
Romania
State/province [86] 0 0
Baia Mare Maramures
Country [87] 0 0
Romania
State/province [87] 0 0
Brasov
Country [88] 0 0
Romania
State/province [88] 0 0
Bucharest
Country [89] 0 0
Romania
State/province [89] 0 0
Cluj-Napoca
Country [90] 0 0
Romania
State/province [90] 0 0
Galati
Country [91] 0 0
Romania
State/province [91] 0 0
Oradea
Country [92] 0 0
Romania
State/province [92] 0 0
Sibiu
Country [93] 0 0
Romania
State/province [93] 0 0
Targu-Mures
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Arkhangelsk
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Moscow
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Samara
Country [97] 0 0
Russian Federation
State/province [97] 0 0
St. Petersburg
Country [98] 0 0
Spain
State/province [98] 0 0
Barcelona
Country [99] 0 0
Spain
State/province [99] 0 0
Hospitalet de Llobegrat
Country [100] 0 0
Spain
State/province [100] 0 0
Palma de Mallorca
Country [101] 0 0
Spain
State/province [101] 0 0
Tarragona
Country [102] 0 0
Sweden
State/province [102] 0 0
Järfälla
Country [103] 0 0
Sweden
State/province [103] 0 0
Rättvik
Country [104] 0 0
Sweden
State/province [104] 0 0
Skene
Country [105] 0 0
Taiwan
State/province [105] 0 0
Chiayi
Country [106] 0 0
Taiwan
State/province [106] 0 0
Kaohsiung
Country [107] 0 0
Taiwan
State/province [107] 0 0
New Taipei
Country [108] 0 0
Taiwan
State/province [108] 0 0
Taichung
Country [109] 0 0
Taiwan
State/province [109] 0 0
Tainan
Country [110] 0 0
Taiwan
State/province [110] 0 0
Taipei

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
Trial website
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

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