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NCT01734785 Clinical Trial

Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01734785
Other study ID # 1275.9
Secondary ID 2012-002270-31
Status Completed
Phase Phase 3
First received November 16, 2012
Last updated April 1, 2015
Start date January 2013
Est. completion date March 2015

Study information
Verified date April 2015
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Dept of Health and Ageing Therapeutic Goods AdministrationBrazil: Ministry of HealthCanada: Health CanadaFrance: Agence Nationale de Sécurité du Médicament et des produits de santéNew Zealand: MedsafeNorway: Norwegian Medicines AgencySouth Korea: Ministry of Food and Drug Safety (MFDS)Spain: Spanish Agency of MedicinesTaiwan : Food and Drug AdministrationUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial will compare the use of the FDC of empagliflozin and linagliptin to linagliptin alone as add-on to metformin in patients with T2DM.

Recruitment information / eligibility
Status Completed
Enrollment 607
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Linagliptin
tablet
• Empagliflozin + Linagliptin
Fixed dose combination.
• Empagliflozin + Linagliptin
Fixed dose combination
• Empagliflozin + Linagliptin
Fixed dose combination
• Empaglifozin placebo + Linagliptin placebo
Matching Empaglifozin + Linagliptin low dose
• Empagliflozin + Linagliptin
Fixed dose combination.

Locations
Country Name City State
Australia 1275.9.61003 Boehringer Ingelheim Investigational Site Carina Heights Queensland
Australia 1275.9.61002 Boehringer Ingelheim Investigational Site Herston Queensland
Australia 1275.9.61009 Boehringer Ingelheim Investigational Site Liverpool New South Wales
Australia 1275.9.61006 Boehringer Ingelheim Investigational Site Malvern Victoria
Australia 1275.9.61007 Boehringer Ingelheim Investigational Site Nedlands Western Australia
Australia 1275.9.61001 Boehringer Ingelheim Investigational Site St Leonards New South Wales
Brazil 1275.9.55002 Boehringer Ingelheim Investigational Site Brasilia
Brazil 1275.9.55005 Boehringer Ingelheim Investigational Site Goiania
Brazil 1275.9.55001 Boehringer Ingelheim Investigational Site Sao Paulo
Brazil 1275.9.55003 Boehringer Ingelheim Investigational Site Sao Paulo
Brazil 1275.9.55004 Boehringer Ingelheim Investigational Site Sao Paulo
Canada 1275.9.01101 Boehringer Ingelheim Investigational Site Burnaby British Columbia
Canada 1275.9.01105 Boehringer Ingelheim Investigational Site Cornwall Ontario
Canada 1275.9.01106 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1275.9.01104 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1275.9.01103 Boehringer Ingelheim Investigational Site Victoria British Columbia
Canada 1275.9.01102 Boehringer Ingelheim Investigational Site Waterloo Ontario
El Salvador 1275.9.34008 Boehringer Ingelheim Investigational Site Barcelona
France 1275.9.33006 Boehringer Ingelheim Investigational Site Bourg des Comptes
France 1275.9.33008 Boehringer Ingelheim Investigational Site Dessenheim
France 1275.9.33003 Boehringer Ingelheim Investigational Site La Riche
France 1275.9.33012 Boehringer Ingelheim Investigational Site Paris
France 1275.9.33002 Boehringer Ingelheim Investigational Site Saint Avertin
France 1275.9.33005 Boehringer Ingelheim Investigational Site Savonnieres
France 1275.9.33004 Boehringer Ingelheim Investigational Site Tours
Korea, Republic of 1275.9.82006 Boehringer Ingelheim Investigational Site Daejeon
Korea, Republic of 1275.9.82009 Boehringer Ingelheim Investigational Site Deagu
Korea, Republic of 1275.9.82002 Boehringer Ingelheim Investigational Site Goyang
Korea, Republic of 1275.9.82004 Boehringer Ingelheim Investigational Site Seongnam
Korea, Republic of 1275.9.82001 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1275.9.82005 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1275.9.82007 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1275.9.82008 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1275.9.82010 Boehringer Ingelheim Investigational Site Seoul
New Zealand 1275.9.64005 Boehringer Ingelheim Investigational Site Auckland, New Zealand
New Zealand 1275.9.64006 Boehringer Ingelheim Investigational Site Auckland, New Zealand
New Zealand 1275.9.64008 Boehringer Ingelheim Investigational Site Birkenhead Auckland
New Zealand 1275.9.64004 Boehringer Ingelheim Investigational Site Christchurch, New Zealand
New Zealand 1275.9.64002 Boehringer Ingelheim Investigational Site Otahuhu Auckland
New Zealand 1275.9.64007 Boehringer Ingelheim Investigational Site Shirley Christchurch
New Zealand 1275.9.64001 Boehringer Ingelheim Investigational Site Takapuna Auckland
New Zealand 1275.9.64003 Boehringer Ingelheim Investigational Site Tauranga, New Zealand
Norway 1275.9.47001 Boehringer Ingelheim Investigational Site Bergen
Norway 1275.9.47002 Boehringer Ingelheim Investigational Site Oslo
Norway 1275.9.47003 Boehringer Ingelheim Investigational Site Oslo
Norway 1275.9.47007 Boehringer Ingelheim Investigational Site Oslo
Norway 1275.9.47006 Boehringer Ingelheim Investigational Site Svelvik
Spain 1275.9.34011 Boehringer Ingelheim Investigational Site A Coruña
Spain 1275.9.34009 Boehringer Ingelheim Investigational Site Alicante
Spain 1275.9.34005 Boehringer Ingelheim Investigational Site Badía del Vallès - Barcelona
Spain 1275.9.34001 Boehringer Ingelheim Investigational Site Barcelona
Spain 1275.9.34003 Boehringer Ingelheim Investigational Site Barcelona
Spain 1275.9.34004 Boehringer Ingelheim Investigational Site Barcelona
Spain 1275.9.34002 Boehringer Ingelheim Investigational Site Sevilla
Spain 1275.9.34010 Boehringer Ingelheim Investigational Site Valencia
Spain 1275.9.34006 Boehringer Ingelheim Investigational Site Vic
Taiwan 1275.9.88606 Boehringer Ingelheim Investigational Site Kaohsiung
Taiwan 1275.9.88607 Boehringer Ingelheim Investigational Site Kaohsiung
Taiwan 1275.9.88602 Boehringer Ingelheim Investigational Site New Taipei
Taiwan 1275.9.88603 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1275.9.88604 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1275.9.88605 Boehringer Ingelheim Investigational Site Tainan
Taiwan 1275.9.88608 Boehringer Ingelheim Investigational Site Taipei
United States 1275.9.01016 Boehringer Ingelheim Investigational Site Asheboro North Carolina
United States 1275.9.01029 Boehringer Ingelheim Investigational Site Blue Ridge Georgia
United States 1275.9.01025 Boehringer Ingelheim Investigational Site Burlington North Carolina
United States 1275.9.01031 Boehringer Ingelheim Investigational Site Chicago Illinois
United States 1275.9.01010 Boehringer Ingelheim Investigational Site Coral Gables Florida
United States 1275.9.01032 Boehringer Ingelheim Investigational Site Corpus Christi Texas
United States 1275.9.01005 Boehringer Ingelheim Investigational Site Corvallis Oregon
United States 1275.9.01018 Boehringer Ingelheim Investigational Site Dayton Ohio
United States 1275.9.01013 Boehringer Ingelheim Investigational Site Gulf Shores Alabama
United States 1275.9.01030 Boehringer Ingelheim Investigational Site Houston Texas
United States 1275.9.01003 Boehringer Ingelheim Investigational Site Marietta Georgia
United States 1275.9.01019 Boehringer Ingelheim Investigational Site Methuen Massachusetts
United States 1275.9.01004 Boehringer Ingelheim Investigational Site Miami Florida
United States 1275.9.01007 Boehringer Ingelheim Investigational Site Newington New Hampshire
United States 1275.9.01011 Boehringer Ingelheim Investigational Site Northglenn Colorado
United States 1275.9.01009 Boehringer Ingelheim Investigational Site Norwalk California
United States 1275.9.01006 Boehringer Ingelheim Investigational Site Oldsmar Florida
United States 1275.9.01002 Boehringer Ingelheim Investigational Site Omaha Nebraska
United States 1275.9.01001 Boehringer Ingelheim Investigational Site Palm Coast Florida
United States 1275.9.01027 Boehringer Ingelheim Investigational Site Port Orange Florida
United States 1275.9.01021 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1275.9.01015 Boehringer Ingelheim Investigational Site San Diego California
United States 1275.9.01017 Boehringer Ingelheim Investigational Site San Diego California
United States 1275.9.01022 Boehringer Ingelheim Investigational Site Savannah Georgia
United States 1275.9.01014 Boehringer Ingelheim Investigational Site Shelby North Carolina
United States 1275.9.01023 Boehringer Ingelheim Investigational Site St. Louis Missouri
United States 1275.9.01024 Boehringer Ingelheim Investigational Site Troy Michigan
United States 1275.9.01028 Boehringer Ingelheim Investigational Site Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  El Salvador,  France,  Korea, Republic of,  New Zealand,  Norway,  Spain,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c change from baseline after 24 weeks double-blind randomized treatment 24 WEEKS No
Secondary Fasting plasma glucose (FPG) change from baseline after 24 weeks of double-blind treatment. 24 WEEKS No
Secondary Body weight change from baseline after 24 weeks of double-blind treatment 24 WEEKS No
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