Clinical trial NCT00915772: Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
Official title: Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46


Eligibility criteria: Inclusion criteria:

* Signed and dated written informed consent, at the latest by the date of Visit 1
* Patients completing the entire treatment period of the double-blind study 1218.46, who are not treated with rescue medication (Visit 7)

Exclusion criteria:

* Patients who meet one or more of the withdrawal criteria of the treatment period of the previous study 1218.46
* Pre-menopausal women (last menstruation equal or less than 1 year prior to signing informed consent) who:
* are nursing or pregnant,
* or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner and in addition for male partners a barrier method, such as the use of condom with spermicide. No exception will be made.
* Alcohol abuse within the 3 months prior to informed consent that would interfere with study participation
* Drug abuse that in the opinion of the investigator would interfere with trial participation
* Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the study medication

Primary outcomes:
measure: Frequency of Patients With Adverse Events (AEs)
timeFrame: 54 weeks
measure: Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
timeFrame: 54 weeks
measure: Change From Baseline at Week 54 in Pulse Rate
timeFrame: 54 weeks
measure: Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology
timeFrame: 54 weeks
measure: Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry
timeFrame: 54 weeks
measure: Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE
timeFrame: Baseline and drug stop (up to 54 weeks) + 7 days
Secondary outcomes:
measure: Change in HbA1c From Baseline Over Time
timeFrame: 54 weeks
measure: Number of Patients With HbA1c <7.0% After 54 Weeks
timeFrame: 54 weeks
measure: Number of Patients With HbA1c <6.5% Over Time
timeFrame: 54 weeks
measure: Number of Patients With HbA1c of at Least <0.5% Over Time
timeFrame: 54 weeks
measure: Change in FPG From Baseline Over Time
timeFrame: 54 weeks
measure: Number of Patients With Rescue Therapy
timeFrame: 54 weeks
measure: Change in HbA1c From Baseline Over Time
timeFrame: 78 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: 1218.52.11005 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1218.52.11003 Boehringer Ingelheim Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: 1218.52.11002 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1218.52.11006 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 1218.52.11008 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: 1218.52.11004 Boehringer Ingelheim Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: 1218.52.11007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1218.52.11010 Boehringer Ingelheim Investigational Site
state: Ontario
city: Karlovac
country: Croatia
facility: 1218.52.38502 Boehringer Ingelheim Investigational Site
city: Krapinske Toplice
country: Croatia
facility: 1218.52.38503 Boehringer Ingelheim Investigational Site
city: Osijek
country: Croatia
facility: 1218.52.38504 Boehringer Ingelheim Investigational Site
city: Rijeka
country: Croatia
facility: 1218.52.38505 Boehringer Ingelheim Investigational Site
city: Sisak
country: Croatia
facility: 1218.52.38501 Boehringer Ingelheim Investigational Site
city: Pärnu
country: Estonia
facility: 1218.52.37202 Boehringer Ingelheim Investigational Site
city: Tallin
country: Estonia
facility: 1218.52.37201 Boehringer Ingelheim Investigational Site
city: Tallin
country: Estonia
facility: 1218.52.37203 Boehringer Ingelheim Investigational Site
city: Aire sur l'Aadour
country: France
facility: 1218.52.3303D Boehringer Ingelheim Investigational Site
city: Bischheim
country: France
facility: 1218.52.3308B Boehringer Ingelheim Investigational Site
city: Bourges
country: France
facility: 1218.52.3305A Boehringer Ingelheim Investigational Site
city: Bousse
country: France
facility: 1218.52.3304F Boehringer Ingelheim Investigational Site
city: Gambsheim
country: France
facility: 1218.52.3308C Boehringer Ingelheim Investigational Site
city: Grenoble cédex
country: France
facility: 1218.52.3301A Boehringer Ingelheim Investigational Site
city: Guerigny
country: France
facility: 1218.52.3305B Boehringer Ingelheim Investigational Site
city: Jarny
country: France
facility: 1218.52.3304A Boehringer Ingelheim Investigational Site
city: La Riche
country: France
facility: 1218.52.3302D Boehringer Ingelheim Investigational Site
city: La Riche
country: France
facility: 1218.52.9999 Boehringer Ingelheim Investigational Site
city: La Seyne sur Mer
country: France
facility: 1218.52.3307A Boehringer Ingelheim Investigational Site
city: La Seyne sur Mer
country: France
facility: 1218.52.3307E Boehringer Ingelheim Investigational Site
city: Lury
country: France
facility: 1218.52.3305G Boehringer Ingelheim Investigational Site
city: Mont de Marsan
country: France
facility: 1218.52.3303A Boehringer Ingelheim Investigational Site
city: Mundolsheim
country: France
facility: 1218.52.3308F Boehringer Ingelheim Investigational Site
city: Nevers
country: France
facility: 1218.52.3305E Boehringer Ingelheim Investigational Site
city: Ortez
country: France
facility: 1218.52.3306A Boehringer Ingelheim Investigational Site
city: Orthez
country: France
facility: 1218.52.3306C Boehringer Ingelheim Investigational Site
city: Savonnières
country: France
facility: 1218.52.3302E Boehringer Ingelheim Investigational Site
city: St Martin d'Oney
country: France
facility: 1218.52.3303B Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1218.52.3308A Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1218.52.3308D Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1218.52.3308E Boehringer Ingelheim Investigational Site
city: Toulon
country: France
facility: 1218.52.3307D Boehringer Ingelheim Investigational Site
city: Tours
country: France
facility: 1218.52.3302A Boehringer Ingelheim Investigational Site
city: Bad Dürrheim-Sunthausen
country: Germany
facility: 1218.52.49002 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1218.52.49006 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1218.52.49003 Boehringer Ingelheim Investigational Site
city: Schauenburg
country: Germany
facility: 1218.52.49007 Boehringer Ingelheim Investigational Site
city: Aurangabad
country: India
facility: 1218.52.91009 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.52.91001 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.52.91004 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.52.91012 Boehringer Ingelheim Investigational Site
city: Bhopal
country: India
facility: 1218.52.91011 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1218.52.91003 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1218.52.91020 Boehringer Ingelheim Investigational Site
city: Hyderadad
country: India
facility: 1218.52.91018 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1218.52.91008 Boehringer Ingelheim Investigational Site
city: Karnataka
country: India
facility: 1218.52.91002 Boehringer Ingelheim Investigational Site
city: Karnataka
country: India
facility: 1218.52.91007 Boehringer Ingelheim Investigational Site
city: Madurai
country: India
facility: 1218.52.91019 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 1218.52.91013 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1218.52.91015 Boehringer Ingelheim Investigational Site
city: Nagpru
country: India
facility: 1218.52.91014 Boehringer Ingelheim Investigational Site
city: P.O.Trivandrum
country: India
facility: 1218.52.91016 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1218.52.91010 Boehringer Ingelheim Investigational Site
city: West Bengal
country: India
facility: 1218.52.91006 Boehringer Ingelheim Investigational Site
city: Kaunas
country: Lithuania
facility: 1218.52.37001 Boehringer Ingelheim Investigational Site
city: Kaunas
country: Lithuania
facility: 1218.52.37004 Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: 1218.52.37003 Boehringer Ingelheim Investigational Site
city: Aguascalientes
country: Mexico
facility: 1218.52.52006 Boehringer Ingelheim Investigational Site
city: Cuernavaca
country: Mexico
facility: 1218.52.52002 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1218.52.52004 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1218.52.52007 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1218.52.52008 Boehringer Ingelheim Investigational Site
city: Tijuana
country: Mexico
facility: 1218.52.52010 Boehringer Ingelheim Investigational Site
city: Veracruz
country: Mexico
facility: 1218.52.52009 Boehringer Ingelheim Investigational Site
city: 's Hertogenbosch
country: Netherlands
facility: 1218.52.31004 Boehringer Ingelheim Investigational Site
city: 's Hertogenbosch
country: Netherlands
facility: 1218.52.31005 Boehringer Ingelheim Investigational Site
city: Almere
country: Netherlands
facility: 1218.52.31001 Boehringer Ingelheim Investigational Site
city: Beek en Donk
country: Netherlands
facility: 1218.52.31002 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1218.52.31010 Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: 1218.52.31013 Boehringer Ingelheim Investigational Site
city: Velp
country: Netherlands
facility: 1218.52.31014 Boehringer Ingelheim Investigational Site
city: Zoetermeer
country: Netherlands
facility: 1218.52.31015 Boehringer Ingelheim Investigational Site
city: Alba Iulia
country: Romania
facility: 1218.52.40001 Boehringer Ingelheim Investigational Site
city: Galati
country: Romania
facility: 1218.52.40005 Boehringer Ingelheim Investigational Site
city: Oradea
country: Romania
facility: 1218.52.40003 Boehringer Ingelheim Investigational Site
city: Ploiesti
country: Romania
facility: 1218.52.40002 Boehringer Ingelheim Investigational Site
city: Satu Mare
country: Romania
facility: 1218.52.40004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.52.70001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.52.70002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.52.70003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.52.70004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.52.70006 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.52.70005 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.52.70007 Boehringer Ingelheim Investigational Site
city: Goteborg
country: Sweden
facility: 1218.52.46002 Boehringer Ingelheim Investigational Site
city: Malmo
country: Sweden
facility: 1218.52.46003 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1218.52.46005 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1218.52.46001 Boehringer Ingelheim Investigational Site
city: Bab Saâdoun Tunis
country: Tunisia
facility: 1218.52.2162A Boehringer Ingelheim Investigational Site
city: Bab Sâadoun Tunis
country: Tunisia
facility: 1218.52.2162B Boehringer Ingelheim Investigational Site
city: Bab Sâadoun Tunis
country: Tunisia
facility: 1218.52.9992 Boehringer Ingelheim Investigational Site
city: Tunis
country: Tunisia
facility: 1218.52.2161A Boehringer Ingelheim Investigational Site
city: Tunis
country: Tunisia
facility: 1218.52.2161B Boehringer Ingelheim Investigational Site
city: Tunis
country: Tunisia
facility: 1218.52.2163A Boehringer Ingelheim Investigational Site
city: Tunis
country: Tunisia
facility: 1218.52.2163B Boehringer Ingelheim Investigational Site
city: Tunis
country: Tunisia
facility: 1218.52.9991 Boehringer Ingelheim Investigational Site
city: Tunis
country: Tunisia
facility: 1218.52.9993 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.52.38003 Boehringer Ingelheim Investigational Site
city: Lviv
country: Ukraine
facility: 1218.52.38001 Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: 1218.52.38005 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1218.52.38002 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1218.52.38004 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1218.52.38006 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: