Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

NCT00915772 | Completed Phase 3 Results

• 2 other identifiers: 1218.522008-008494-59
• Study Type: interventional
• Target: 567
• Locations: 14 countries
• Sites: 112

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (6)

• Frequency of Patients With Adverse Events (AEs)

  This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.

  54 weeks

• Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

  Baseline is defined as Visit 1 of 1218.52.

  54 weeks

• Change From Baseline at Week 54 in Pulse Rate

  Baseline is defined as Visit 1 of 1218.52.

  54 weeks

• Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology

  54 weeks

• Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry

  ULN means upper limit of normal

  54 weeks

• Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE

  Frequency of patients with adverse events by treatment, primary system organ class and preferred term

  Baseline and drug stop (up to 54 weeks) + 7 days

Secondary Outcomes (7)

• Change in HbA1c From Baseline Over Time

  54 weeks

• Number of Patients With HbA1c <7.0% After 54 Weeks

  54 weeks

• Number of Patients With HbA1c <6.5% Over Time

  54 weeks

• Number of Patients With HbA1c of at Least <0.5% Over Time

  54 weeks

• Change in FPG From Baseline Over Time

  54 weeks

Study Arms (3)

Linagliptin + metformin bid

EXPERIMENTAL

Linagliptin low dose + metformin 500 mg, bid

Drug: Linagliptin + metformin

Linagliptin+ metformin bid

EXPERIMENTAL

Linagliptin low dose + metformin 1000 mg bid

Drug: Linagliptin+metformin

Metformin bid

ACTIVE COMPARATOR

Metformin 1000 mg bid

Drug: Metformin

Interventions

Linagliptin + metformin DRUG

Linagliptin tablet low dose + metformin tablet 500 mg bid

Linagliptin + metformin bid

Linagliptin+metformin DRUG

Linagliptin low dose tablet + metformin 1000 mg tablet bid

Linagliptin+ metformin bid

Metformin DRUG

Metformin 1000 mg tablet bid

Metformin bid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (112)

1218.52.11005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1218.52.11003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1218.52.11002 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

Location

1218.52.11006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1218.52.11008 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1218.52.11004 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1218.52.11007 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Location

1218.52.11010 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1218.52.38502 Boehringer Ingelheim Investigational Site

Karlovac, Croatia

Location

1218.52.38503 Boehringer Ingelheim Investigational Site

Krapinske Toplice, Croatia

Location

1218.52.38504 Boehringer Ingelheim Investigational Site

Osijek, Croatia

Location

1218.52.38505 Boehringer Ingelheim Investigational Site

Rijeka, Croatia

Location

1218.52.38501 Boehringer Ingelheim Investigational Site

Sisak, Croatia

Location

1218.52.37202 Boehringer Ingelheim Investigational Site

Pärnu, Estonia

Location

1218.52.37201 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1218.52.37203 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1218.52.3303D Boehringer Ingelheim Investigational Site

Aire Sur l'Aadour, France

Location

1218.52.3308B Boehringer Ingelheim Investigational Site

Bischheim, France

Location

1218.52.3305A Boehringer Ingelheim Investigational Site

Bourges, France

Location

1218.52.3304F Boehringer Ingelheim Investigational Site

Bousse, France

Location

1218.52.3308C Boehringer Ingelheim Investigational Site

Gambsheim, France

Location

1218.52.3301A Boehringer Ingelheim Investigational Site

Grenoble Cédex, France

Location

1218.52.3305B Boehringer Ingelheim Investigational Site

Guérigny, France

Location

1218.52.3304A Boehringer Ingelheim Investigational Site

Jarny, France

Location

1218.52.3302D Boehringer Ingelheim Investigational Site

La Riche, France

Location

1218.52.9999 Boehringer Ingelheim Investigational Site

La Riche, France

Location

1218.52.3307A Boehringer Ingelheim Investigational Site

La Seyne-sur-Mer, France

Location

1218.52.3307E Boehringer Ingelheim Investigational Site

La Seyne-sur-Mer, France

Location

1218.52.3305G Boehringer Ingelheim Investigational Site

Lury-sur-Arnon, France

Location

1218.52.3303A Boehringer Ingelheim Investigational Site

Mont-de-Marsan, France

Location

1218.52.3308F Boehringer Ingelheim Investigational Site

Mundolsheim, France

Location

1218.52.3305E Boehringer Ingelheim Investigational Site

Nevers, France

Location

1218.52.3306A Boehringer Ingelheim Investigational Site

Orthez, France

Location

1218.52.3306C Boehringer Ingelheim Investigational Site

Orthez, France

Location

1218.52.3303B Boehringer Ingelheim Investigational Site

Saint-Martin-d'Oney, France

Location

1218.52.3302E Boehringer Ingelheim Investigational Site

Savonnières, France

Location

1218.52.3308A Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1218.52.3308D Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1218.52.3308E Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1218.52.3307D Boehringer Ingelheim Investigational Site

Toulon, France

Location

1218.52.3302A Boehringer Ingelheim Investigational Site

Tours, France

Location

1218.52.49002 Boehringer Ingelheim Investigational Site

Bad Dürrheim-Sunthausen, Germany

Location

1218.52.49006 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1218.52.49003 Boehringer Ingelheim Investigational Site

München, Germany

Location

1218.52.49007 Boehringer Ingelheim Investigational Site

Schauenburg, Germany

Location

1218.52.91009 Boehringer Ingelheim Investigational Site

Aurangabad, India

Location

1218.52.91001 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.52.91004 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.52.91012 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.52.91011 Boehringer Ingelheim Investigational Site

Bhopal, India

Location

1218.52.91003 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.52.91020 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.52.91018 Boehringer Ingelheim Investigational Site

Hyderadad, India

Location

1218.52.91008 Boehringer Ingelheim Investigational Site

Jaipur, India

Location

1218.52.91002 Boehringer Ingelheim Investigational Site

Karnataka, India

Location

1218.52.91007 Boehringer Ingelheim Investigational Site

Karnataka, India

Location

1218.52.91019 Boehringer Ingelheim Investigational Site

Madurai, India

Location

1218.52.91013 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

1218.52.91015 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1218.52.91014 Boehringer Ingelheim Investigational Site

Nagpru, India

Location

1218.52.91016 Boehringer Ingelheim Investigational Site

P.O.Trivandrum, India

Location

1218.52.91010 Boehringer Ingelheim Investigational Site

Pune, India

Location

1218.52.91006 Boehringer Ingelheim Investigational Site

West Bengal, India

Location

1218.52.37001 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

1218.52.37004 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

1218.52.37003 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

1218.52.52006 Boehringer Ingelheim Investigational Site

Aguascalientes, Mexico

Location

1218.52.52002 Boehringer Ingelheim Investigational Site

Cuernavaca, Mexico

Location

1218.52.52004 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1218.52.52007 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.52.52008 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.52.52010 Boehringer Ingelheim Investigational Site

Tijuana, Mexico

Location

1218.52.52009 Boehringer Ingelheim Investigational Site

Veracruz, Mexico

Location

1218.52.31004 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1218.52.31005 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1218.52.31001 Boehringer Ingelheim Investigational Site

Almere Stad, Netherlands

Location

1218.52.31002 Boehringer Ingelheim Investigational Site

Beek en Donk, Netherlands

Location

1218.52.31010 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1218.52.31013 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

1218.52.31014 Boehringer Ingelheim Investigational Site

Velp, Netherlands

Location

1218.52.31015 Boehringer Ingelheim Investigational Site

Zoetermeer, Netherlands

Location

1218.52.40001 Boehringer Ingelheim Investigational Site

Alba Iulia, Romania

Location

1218.52.40005 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1218.52.40003 Boehringer Ingelheim Investigational Site

Oradea, Romania

Location

1218.52.40002 Boehringer Ingelheim Investigational Site

Ploieşti, Romania

Location

1218.52.40004 Boehringer Ingelheim Investigational Site

Satu Mare, Romania

Location

1218.52.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.52.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.52.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.52.70004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.52.70006 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.52.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.52.70007 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.52.46002 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1218.52.46003 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1218.52.46005 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1218.52.46001 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1218.52.2162A Boehringer Ingelheim Investigational Site

Bab Saâdoun Tunis, Tunisia

Location

1218.52.2162B Boehringer Ingelheim Investigational Site

Bab Sâadoun Tunis, Tunisia

Location

1218.52.9992 Boehringer Ingelheim Investigational Site

Bab Sâadoun Tunis, Tunisia

Location

1218.52.2161A Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.52.2161B Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.52.2163A Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.52.2163B Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.52.9991 Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.52.9993 Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.52.38003 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.52.38001 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1218.52.38005 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1218.52.38002 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1218.52.38004 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1218.52.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

Related Links

• List of publications

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 8, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Last Updated: May 14, 2014
• Results First Posted: July 18, 2012

Record last verified: 2014-04

Locations

DE (4); FR (25); LI (3); CA (8); IN (18); TU (9); UA (6); ME (7); CR (5); NL (8); RO (5); RU (7); SE (4); ES (3)