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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01778049




Registration number
NCT01778049
Ethics application status
Date submitted
24/01/2013
Date registered
29/01/2013
Date last updated
4/04/2016

Titles & IDs
Public title
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
Scientific title
A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks of Treatment With Empagliflozin 10 mg or 25 mg on Metformin Background Therapy
Secondary ID [1] 0 0
2012-002271-34
Secondary ID [2] 0 0
1275.10
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 - BI 10773
Treatment: Drugs - BI 10773 Placebo
Treatment: Drugs - BI 10773 / BI 1356
Treatment: Drugs - BI 10773
Treatment: Drugs - BI 10773 / BI 1356
Treatment: Drugs - BI 10773 / BI 1356 Placebo
Treatment: Drugs - BI 10773
Treatment: Drugs - BI 10773
Treatment: Drugs - BI 10773
Treatment: Drugs - BI 10773 / BI 1356 Placebo
Treatment: Drugs - BI 10773 Placebo
Treatment: Drugs - BI 10773 / BI 1356 Placebo
Treatment: Drugs - BI 10773
Treatment: Drugs - BI 10773 / BI 1356 Placebo

Experimental: Empagliflozin 10 mg dose - Empagliflozin open label treatment period

Experimental: Placebo add on 10 mg dose - Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in

Experimental: Empagliflozin/Linagliptin 25/5 mg Dose - Empagliflozin / Linagliptin 25/5 mg Dose FDC active

Experimental: Empagliflozin/Linagliptin 10/5 mg Dose. - Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo

Experimental: Empagliflozin/Linagliptin 10/5 mg Dose - Empagliflozin / Linagliptin 10/5 mg Dose FDC active

Experimental: Empagliflozin 25 mg dose - Empagliflozin open label treatment period

Experimental: Empagliflozin/Linagliptin 25/5 mg Dose. - Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Experimental: Placebo add on 25 mg dose - Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in


Treatment: Drugs: BI 10773
Empagliflozin active

Treatment: Drugs: BI 10773 Placebo
Empagliflozin placebo

Treatment: Drugs: BI 10773 / BI 1356
Empagliflozin / Linagliptin 25/5 mg Dose FDC active

Treatment: Drugs: BI 10773
Empagliflozin active

Treatment: Drugs: BI 10773 / BI 1356
Empagliflozin / Linagliptin 10/5 mg Dose FDC active

Treatment: Drugs: BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC

Treatment: Drugs: BI 10773
Empagliflozin active

Treatment: Drugs: BI 10773
Empagliflozin active

Treatment: Drugs: BI 10773
Empagliflozin active

Treatment: Drugs: BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Treatment: Drugs: BI 10773 Placebo
Empagliflozin placebo

Treatment: Drugs: BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo

Treatment: Drugs: BI 10773
Empagliflozin active

Treatment: Drugs: BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline of HbA1c After 24 Weeks of Treatment.
Timepoint [1] 0 0
Baseline and 24 weeks
Secondary outcome [1] 0 0
Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.
Timepoint [1] 0 0
Baseline and 24 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Signed and dated ICF (Informed Consent Form)
2. Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label
3. HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1
4. HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4
5. Age > or equal to 18 years
6. BMI (Body Mass Index) < or equal to 45
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 during open label period and placebo add on "run-in" period
2. Use of any other antidiabetic
3. Renal function below 60 ml/min/1.73 m2
4. Antiobesity drugs or aggresive diets
5. Gastorintestinal surgeries
6. Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
7. Acute coronary syndrome and stroke within 3 months of informed consent
8. Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors

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
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
708
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
1275.10.61008 Boehringer Ingelheim Investigational Site - Cardiff
Recruitment hospital [2] 0 0
1275.10.61002 Boehringer Ingelheim Investigational Site - East Ringwood
Recruitment hospital [3] 0 0
1275.10.61001 Boehringer Ingelheim Investigational Site - Heidelberg Heights
Recruitment hospital [4] 0 0
1275.10.61009 Boehringer Ingelheim Investigational Site - Mirrabooka
Recruitment postcode(s) [1] 0 0
- Cardiff
Recruitment postcode(s) [2] 0 0
- East Ringwood
Recruitment postcode(s) [3] 0 0
- Heidelberg Heights
Recruitment postcode(s) [4] 0 0
- Mirrabooka
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
North Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Argentina
State/province [15] 0 0
Caba
Country [16] 0 0
Argentina
State/province [16] 0 0
Capital Federal
Country [17] 0 0
Argentina
State/province [17] 0 0
Cordoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Córdoba
Country [19] 0 0
Argentina
State/province [19] 0 0
Godoy Cruz, Mendoza
Country [20] 0 0
Argentina
State/province [20] 0 0
Mar del Plata
Country [21] 0 0
Argentina
State/province [21] 0 0
Salta
Country [22] 0 0
Argentina
State/province [22] 0 0
San Isidro
Country [23] 0 0
Argentina
State/province [23] 0 0
Zarate
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Manitoba
Country [27] 0 0
Canada
State/province [27] 0 0
New Brunswick
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
El Salvador
State/province [30] 0 0
Ávila
Country [31] 0 0
Germany
State/province [31] 0 0
Asslar
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Germany
State/province [32] 0 0
Berlin
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Germany
State/province [33] 0 0
Elsterwerda
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Germany
State/province [34] 0 0
Hamburg
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Germany
State/province [35] 0 0
Hatten
Country [36] 0 0
Germany
State/province [36] 0 0
Kiel Kronshagen
Country [37] 0 0
Germany
State/province [37] 0 0
Köln
Country [38] 0 0
Germany
State/province [38] 0 0
Lübeck
Country [39] 0 0
Germany
State/province [39] 0 0
Münster
Country [40] 0 0
Germany
State/province [40] 0 0
Pirna
Country [41] 0 0
Germany
State/province [41] 0 0
St. Ingbert/Oberwürzbach
Country [42] 0 0
Germany
State/province [42] 0 0
Unterschneidheim
Country [43] 0 0
Germany
State/province [43] 0 0
Wangen
Country [44] 0 0
Italy
State/province [44] 0 0
Ancona
Country [45] 0 0
Italy
State/province [45] 0 0
Catania
Country [46] 0 0
Italy
State/province [46] 0 0
Latina
Country [47] 0 0
Italy
State/province [47] 0 0
Milano
Country [48] 0 0
Italy
State/province [48] 0 0
Olbia (OT)
Country [49] 0 0
Italy
State/province [49] 0 0
Orbassano (TO)
Country [50] 0 0
Italy
State/province [50] 0 0
Palermo
Country [51] 0 0
Italy
State/province [51] 0 0
Pistoia
Country [52] 0 0
Italy
State/province [52] 0 0
Roma
Country [53] 0 0
Italy
State/province [53] 0 0
Sesto San Giovanni (MI)
Country [54] 0 0
Italy
State/province [54] 0 0
Siena
Country [55] 0 0
Italy
State/province [55] 0 0
Terni
Country [56] 0 0
Portugal
State/province [56] 0 0
Cantanhede
Country [57] 0 0
Portugal
State/province [57] 0 0
Porto
Country [58] 0 0
Portugal
State/province [58] 0 0
Sandim
Country [59] 0 0
Portugal
State/province [59] 0 0
Tornada
Country [60] 0 0
Portugal
State/province [60] 0 0
Valadares
Country [61] 0 0
Portugal
State/province [61] 0 0
Vila Nova de Gaia
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Chelyabinsk
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Saint-Petersburg
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Saratov
Country [65] 0 0
Russian Federation
State/province [65] 0 0
St. Petersburg
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Yaroslavl
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona
Country [68] 0 0
Spain
State/province [68] 0 0
Canet de Mar
Country [69] 0 0
Spain
State/province [69] 0 0
Centelles
Country [70] 0 0
Spain
State/province [70] 0 0
L'Hospitalet de Llobregat (Barcelona)
Country [71] 0 0
Spain
State/province [71] 0 0
La Roca del Vallès
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid
Country [73] 0 0
Spain
State/province [73] 0 0
Malaga
Country [74] 0 0
Spain
State/province [74] 0 0
Mataró
Country [75] 0 0
Spain
State/province [75] 0 0
Málaga
Country [76] 0 0
Spain
State/province [76] 0 0
Pineda de Mar
Country [77] 0 0
Spain
State/province [77] 0 0
Sabadell
Country [78] 0 0
Spain
State/province [78] 0 0
Tarragona
Country [79] 0 0
Ukraine
State/province [79] 0 0
Chernivtsi
Country [80] 0 0
Ukraine
State/province [80] 0 0
Dnipropetrovs'k
Country [81] 0 0
Ukraine
State/province [81] 0 0
Kiev
Country [82] 0 0
Ukraine
State/province [82] 0 0
Lviv
Country [83] 0 0
Ukraine
State/province [83] 0 0
Vinnitsa
Country [84] 0 0
Ukraine
State/province [84] 0 0
Zhytomyr

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/NCT01778049