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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
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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
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Secondary ID [1]
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2012-002271-34
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Secondary ID [2]
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1275.10
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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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Condition category
Condition code
Metabolic and Endocrine
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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 - 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
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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 of HbA1c After 24 Weeks of Treatment.
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Assessment method [1]
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Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.
Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.
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Timepoint [1]
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Baseline and 24 weeks
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Secondary outcome [1]
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Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.
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Assessment method [1]
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Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.
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Timepoint [1]
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Baseline and 24 weeks
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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
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Minimum age
18
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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 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
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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
1/01/2013
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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
1/03/2015
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Sample size
Target
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Accrual to date
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Final
708
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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1275.10.61008 Boehringer Ingelheim Investigational Site - Cardiff
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Recruitment hospital [2]
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1275.10.61002 Boehringer Ingelheim Investigational Site - East Ringwood
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Recruitment hospital [3]
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1275.10.61001 Boehringer Ingelheim Investigational Site - Heidelberg Heights
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1275.10.61009 Boehringer Ingelheim Investigational Site - Mirrabooka
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- Cardiff
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- East Ringwood
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- Heidelberg Heights
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Recruitment postcode(s) [4]
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- Mirrabooka
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Zhytomyr
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Other collaborator category [1]
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Eli Lilly and Company
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01778049
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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.
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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 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
Download to PDF