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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
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United States of America
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California
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Florida
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Georgia
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Indiana
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Maryland
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Michigan
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North Carolina
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North Dakota
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Oklahoma
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South Carolina
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Utah
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Virginia
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Argentina
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Caba
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Argentina
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Capital Federal
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Cordoba
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Córdoba
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Godoy Cruz, Mendoza
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Mar del Plata
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Salta
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San Isidro
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Zarate
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Canada
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Alberta
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British Columbia
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Manitoba
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New Brunswick
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Ontario
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Quebec
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El Salvador
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Ávila
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Asslar
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Berlin
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Elsterwerda
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Hamburg
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Hatten
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Kiel Kronshagen
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Köln
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Lübeck
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Münster
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Pirna
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St. Ingbert/Oberwürzbach
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Unterschneidheim
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Germany
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Wangen
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Italy
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Ancona
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Catania
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Latina
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Milano
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Olbia (OT)
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Italy
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Orbassano (TO)
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Italy
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Palermo
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Pistoia
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Roma
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Italy
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Sesto San Giovanni (MI)
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Italy
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Siena
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Italy
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Terni
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Portugal
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Cantanhede
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Porto
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Sandim
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Tornada
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Valadares
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Portugal
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Vila Nova de Gaia
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Russian Federation
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Chelyabinsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
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Yaroslavl
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Spain
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Barcelona
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Canet de Mar
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Spain
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Centelles
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Spain
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L'Hospitalet de Llobregat (Barcelona)
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Spain
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La Roca del Vallès
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Spain
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Madrid
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Malaga
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Mataró
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Málaga
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Pineda de Mar
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Spain
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Sabadell
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Spain
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Tarragona
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Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovs'k
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Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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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
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
Trial website
https://clinicaltrials.gov/study/NCT01778049
Trial related presentations / publications
Tinahones FJ, Gallwitz B, Nordaby M, Gotz S, Maldonado-Lutomirsky M, Woerle HJ, Broedl UC. Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials. Diabetes Obes Metab. 2017 Feb;19(2):266-274. doi: 10.1111/dom.12814. Epub 2016 Nov 24.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01778049