Clinical trial NCT01734785: Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2012-11-28
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

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.

Primary outcomes:
measure: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.
timeFrame: Baseline and 24 weeks
measure: Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Gulf Shores
country: United States
facility: 1275.9.01013 Boehringer Ingelheim Investigational Site
state: Alabama
city: Norwalk
country: United States
facility: 1275.9.01009 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1275.9.01015 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1275.9.01017 Boehringer Ingelheim Investigational Site
state: California
city: Northglenn
country: United States
facility: 1275.9.01011 Boehringer Ingelheim Investigational Site
state: Colorado
city: Coral Gables
country: United States
facility: 1275.9.01010 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1275.9.01004 Boehringer Ingelheim Investigational Site
state: Florida
city: Oldsmar
country: United States
facility: 1275.9.01006 Boehringer Ingelheim Investigational Site
state: Florida
city: Palm Coast
country: United States
facility: 1275.9.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: Port Orange
country: United States
facility: 1275.9.01027 Boehringer Ingelheim Investigational Site
state: Florida
city: Blue Ridge
country: United States
facility: 1275.9.01029 Boehringer Ingelheim Investigational Site
state: Georgia
city: Marietta
country: United States
facility: 1275.9.01003 Boehringer Ingelheim Investigational Site
state: Georgia
city: Savannah
country: United States
facility: 1275.9.01022 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1275.9.01031 Boehringer Ingelheim Investigational Site
state: Illinois
city: Methuen
country: United States
facility: 1275.9.01019 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Troy
country: United States
facility: 1275.9.01024 Boehringer Ingelheim Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: 1275.9.01023 Boehringer Ingelheim Investigational Site
state: Missouri
city: Omaha
country: United States
facility: 1275.9.01002 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Newington
country: United States
facility: 1275.9.01007 Boehringer Ingelheim Investigational Site
state: New Hampshire
city: Asheboro
country: United States
facility: 1275.9.01016 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Burlington
country: United States
facility: 1275.9.01025 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: 1275.9.01014 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1275.9.01028 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Dayton
country: United States
facility: 1275.9.01018 Boehringer Ingelheim Investigational Site
state: Ohio
city: Corvallis
country: United States
facility: 1275.9.01005 Boehringer Ingelheim Investigational Site
state: Oregon
city: Corpus Christi
country: United States
facility: 1275.9.01032 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1275.9.01030 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1275.9.01021 Boehringer Ingelheim Investigational Site
state: Texas
city: Liverpool
country: Australia
facility: 1275.9.61009 Boehringer Ingelheim Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: 1275.9.61001 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Carina Heights
country: Australia
facility: 1275.9.61003 Boehringer Ingelheim Investigational Site
state: Queensland
city: Herston
country: Australia
facility: 1275.9.61002 Boehringer Ingelheim Investigational Site
state: Queensland
city: Malvern
country: Australia
facility: 1275.9.61006 Boehringer Ingelheim Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: 1275.9.61007 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Brasilia
country: Brazil
facility: 1275.9.55002 Boehringer Ingelheim Investigational Site
city: Goiania
country: Brazil
facility: 1275.9.55005 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1275.9.55001 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1275.9.55003 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1275.9.55004 Boehringer Ingelheim Investigational Site
city: Burnaby
country: Canada
facility: 1275.9.01101 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: 1275.9.01103 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Cornwall
country: Canada
facility: 1275.9.01105 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1275.9.01106 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1275.9.01104 Boehringer Ingelheim Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: 1275.9.01102 Boehringer Ingelheim Investigational Site
state: Ontario
city: Barcelona
country: El Salvador
facility: 1275.9.34008 Boehringer Ingelheim Investigational Site
city: Bourg des Comptes
country: France
facility: 1275.9.33006 Boehringer Ingelheim Investigational Site
city: Dessenheim
country: France
facility: 1275.9.33008 Boehringer Ingelheim Investigational Site
city: La Riche
country: France
facility: 1275.9.33003 Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1275.9.33012 Boehringer Ingelheim Investigational Site
city: Saint Avertin
country: France
facility: 1275.9.33002 Boehringer Ingelheim Investigational Site
city: Savonnieres
country: France
facility: 1275.9.33005 Boehringer Ingelheim Investigational Site
city: Tours
country: France
facility: 1275.9.33004 Boehringer Ingelheim Investigational Site
city: Daejeon
country: Korea, Republic of
facility: 1275.9.82006 Boehringer Ingelheim Investigational Site
city: Deagu
country: Korea, Republic of
facility: 1275.9.82009 Boehringer Ingelheim Investigational Site
city: Goyang
country: Korea, Republic of
facility: 1275.9.82002 Boehringer Ingelheim Investigational Site
city: Seongnam
country: Korea, Republic of
facility: 1275.9.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1275.9.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1275.9.82005 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1275.9.82007 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1275.9.82008 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1275.9.82010 Boehringer Ingelheim Investigational Site
city: Auckland, New Zealand
country: New Zealand
facility: 1275.9.64005 Boehringer Ingelheim Investigational Site
city: Auckland, New Zealand
country: New Zealand
facility: 1275.9.64006 Boehringer Ingelheim Investigational Site
city: Birkenhead Auckland
country: New Zealand
facility: 1275.9.64008 Boehringer Ingelheim Investigational Site
city: Christchurch Central
country: New Zealand
facility: 1275.9.64007 Boehringer Ingelheim Investigational Site
city: Christchurch, New Zealand
country: New Zealand
facility: 1275.9.64004 Boehringer Ingelheim Investigational Site
city: Otahuhu Auckland
country: New Zealand
facility: 1275.9.64002 Boehringer Ingelheim Investigational Site
city: Takapuna Auckland
country: New Zealand
facility: 1275.9.64001 Boehringer Ingelheim Investigational Site
city: Tauranga, New Zealand
country: New Zealand
facility: 1275.9.64003 Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: 1275.9.47001 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1275.9.47002 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1275.9.47003 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1275.9.47007 Boehringer Ingelheim Investigational Site
city: Svelvik
country: Norway
facility: 1275.9.47006 Boehringer Ingelheim Investigational Site
city: A Coruña
country: Spain
facility: 1275.9.34011 Boehringer Ingelheim Investigational Site
city: Alicante
country: Spain
facility: 1275.9.34009 Boehringer Ingelheim Investigational Site
city: Badía Del Vallès - Barcelona
country: Spain
facility: 1275.9.34005 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1275.9.34001 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1275.9.34003 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1275.9.34004 Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: 1275.9.34002 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1275.9.34010 Boehringer Ingelheim Investigational Site
city: Vic
country: Spain
facility: 1275.9.34006 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1275.9.88606 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1275.9.88607 Boehringer Ingelheim Investigational Site
city: New Taipei
country: Taiwan
facility: 1275.9.88602 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1275.9.88603 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1275.9.88604 Boehringer Ingelheim Investigational Site
city: Tainan
country: Taiwan
facility: 1275.9.88605 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Softeland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.