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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01734785




Registration number
NCT01734785
Ethics application status
Date submitted
16/11/2012
Date registered
28/11/2012
Date last updated
11/07/2016

Titles & IDs
Public title
Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
Scientific title
A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.
Secondary ID [1] 0 0
2012-002270-31
Secondary ID [2] 0 0
1275.9
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 - Linagliptin
Treatment: Drugs - Empagliflozin + Linagliptin
Treatment: Drugs - Empagliflozin + Linagliptin
Treatment: Drugs - Empagliflozin + Linagliptin
Treatment: Drugs - Empaglifozin placebo + Linagliptin placebo
Treatment: Drugs - Empagliflozin + Linagliptin

Active Comparator: Linagliptin - 5 mg once daily

Experimental: Empaglifozin + Linagliptin low dose - 1 tablet once daily

Experimental: Empagliflozin + Linagliptin high dose - 1 tablet once daily


Treatment: Drugs: Linagliptin
tablet

Treatment: Drugs: Empagliflozin + Linagliptin
Fixed dose combination.

Treatment: Drugs: Empagliflozin + Linagliptin
Fixed dose combination

Treatment: Drugs: Empagliflozin + Linagliptin
Fixed dose combination

Treatment: Drugs: Empaglifozin placebo + Linagliptin placebo
Matching Empaglifozin + Linagliptin low dose

Treatment: Drugs: Empagliflozin + Linagliptin
Fixed dose combination.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
Timepoint [1] 0 0
Baseline and 24 weeks
Secondary outcome [1] 0 0
Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.
Timepoint [1] 0 0
Baseline and 24 weeks
Secondary outcome [2] 0 0
Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment
Timepoint [2] 0 0
Baseline and 24 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus.

2. Male and female patients on diet and exercise regimen, pre-treated with immediate
release metformin for at least 12 weeks, and patients should be on a dose higher or
equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per
local label.

3. HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.

4. Age 18 years or more at screening.

5. Body Mass Index lower or equal to 45 kg/m2 at screening visit.

6. Signed and dated written informed consent.
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 glucose level above 270 mg/dl (above 15 mmol/dl) after
an overnight fast.

2. Use of any other antidiabetic drug (except metformin background therapy).

3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.

4. Indication of liver disease.

5. Impaired renal function.

6. Gastrointestinal surgery.

7. Treatment with anti-obesity drugs within 3 months prior to screening, or any other
treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.)
leading to unstable body weight.

8. Current treatment with systemic steroids at time of informed consent or uncontrolled
endocrine disorder except type 2 diabetes mellitus.

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
607
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
1275.9.61009 Boehringer Ingelheim Investigational Site - Liverpool
Recruitment hospital [2] 0 0
1275.9.61001 Boehringer Ingelheim Investigational Site - St Leonards
Recruitment hospital [3] 0 0
1275.9.61003 Boehringer Ingelheim Investigational Site - Carina Heights
Recruitment hospital [4] 0 0
1275.9.61002 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [5] 0 0
1275.9.61006 Boehringer Ingelheim Investigational Site - Malvern
Recruitment hospital [6] 0 0
1275.9.61007 Boehringer Ingelheim Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- St Leonards
Recruitment postcode(s) [3] 0 0
- Carina Heights
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Malvern
Recruitment postcode(s) [6] 0 0
- Nedlands
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
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United States of America
State/province [12] 0 0
North Carolina
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United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Brazil
State/province [16] 0 0
Brasilia
Country [17] 0 0
Brazil
State/province [17] 0 0
Goiania
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
El Salvador
State/province [21] 0 0
Barcelona
Country [22] 0 0
France
State/province [22] 0 0
Bourg des Comptes
Country [23] 0 0
France
State/province [23] 0 0
Dessenheim
Country [24] 0 0
France
State/province [24] 0 0
La Riche
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Saint Avertin
Country [27] 0 0
France
State/province [27] 0 0
Savonnieres
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France
State/province [28] 0 0
Tours
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Korea, Republic of
State/province [29] 0 0
Daejeon
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Korea, Republic of
State/province [30] 0 0
Deagu
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Goyang
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Korea, Republic of
State/province [32] 0 0
Seongnam
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
New Zealand
State/province [34] 0 0
Auckland, New Zealand
Country [35] 0 0
New Zealand
State/province [35] 0 0
Birkenhead Auckland
Country [36] 0 0
New Zealand
State/province [36] 0 0
Christchurch Central
Country [37] 0 0
New Zealand
State/province [37] 0 0
Christchurch, New Zealand
Country [38] 0 0
New Zealand
State/province [38] 0 0
Otahuhu Auckland
Country [39] 0 0
New Zealand
State/province [39] 0 0
Takapuna Auckland
Country [40] 0 0
New Zealand
State/province [40] 0 0
Tauranga, New Zealand
Country [41] 0 0
Norway
State/province [41] 0 0
Bergen
Country [42] 0 0
Norway
State/province [42] 0 0
Oslo
Country [43] 0 0
Norway
State/province [43] 0 0
Svelvik
Country [44] 0 0
Spain
State/province [44] 0 0
A Coruña
Country [45] 0 0
Spain
State/province [45] 0 0
Alicante
Country [46] 0 0
Spain
State/province [46] 0 0
Badía del Vallès - Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Sevilla
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia
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Spain
State/province [50] 0 0
Vic
Country [51] 0 0
Taiwan
State/province [51] 0 0
Kaohsiung
Country [52] 0 0
Taiwan
State/province [52] 0 0
New Taipei
Country [53] 0 0
Taiwan
State/province [53] 0 0
Taichung
Country [54] 0 0
Taiwan
State/province [54] 0 0
Tainan

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 compare the use of two different doses of Empagliflozin to placebo, in T2DM
patients on 16 wks linagliptin treatment and metformin background therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01734785
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