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

April 29, 2014 updated by: Boehringer Ingelheim

Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

567

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1218.52.11005 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canada
        • 1218.52.11003 Boehringer Ingelheim Investigational Site
      • Red Deer, Alberta, Canada
        • 1218.52.11002 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1218.52.11006 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1218.52.11008 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1218.52.11004 Boehringer Ingelheim Investigational Site
      • Oakville, Ontario, Canada
        • 1218.52.11007 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1218.52.11010 Boehringer Ingelheim Investigational Site
  • Croatia
      • Karlovac, Croatia
        • 1218.52.38502 Boehringer Ingelheim Investigational Site
      • Krapinske Toplice, Croatia
        • 1218.52.38503 Boehringer Ingelheim Investigational Site
      • Osijek, Croatia
        • 1218.52.38504 Boehringer Ingelheim Investigational Site
      • Rijeka, Croatia
        • 1218.52.38505 Boehringer Ingelheim Investigational Site
      • Sisak, Croatia
        • 1218.52.38501 Boehringer Ingelheim Investigational Site
  • Estonia
      • Pärnu, Estonia
        • 1218.52.37202 Boehringer Ingelheim Investigational Site
      • Tallin, Estonia
        • 1218.52.37201 Boehringer Ingelheim Investigational Site
      • Tallin, Estonia
        • 1218.52.37203 Boehringer Ingelheim Investigational Site
  • France
      • Aire sur l'Aadour, France
        • 1218.52.3303D Boehringer Ingelheim Investigational Site
      • Bischheim, France
        • 1218.52.3308B Boehringer Ingelheim Investigational Site
      • Bourges, France
        • 1218.52.3305A Boehringer Ingelheim Investigational Site
      • Bousse, France
        • 1218.52.3304F Boehringer Ingelheim Investigational Site
      • Gambsheim, France
        • 1218.52.3308C Boehringer Ingelheim Investigational Site
      • Grenoble cédex, France
        • 1218.52.3301A Boehringer Ingelheim Investigational Site
      • Guerigny, France
        • 1218.52.3305B Boehringer Ingelheim Investigational Site
      • Jarny, France
        • 1218.52.3304A Boehringer Ingelheim Investigational Site
      • La Riche, France
        • 1218.52.3302D Boehringer Ingelheim Investigational Site
      • La Riche, France
        • 1218.52.9999 Boehringer Ingelheim Investigational Site
      • La Seyne sur Mer, France
        • 1218.52.3307A Boehringer Ingelheim Investigational Site
      • La Seyne sur Mer, France
        • 1218.52.3307E Boehringer Ingelheim Investigational Site
      • Lury, France
        • 1218.52.3305G Boehringer Ingelheim Investigational Site
      • Mont de Marsan, France
        • 1218.52.3303A Boehringer Ingelheim Investigational Site
      • Mundolsheim, France
        • 1218.52.3308F Boehringer Ingelheim Investigational Site
      • Nevers, France
        • 1218.52.3305E Boehringer Ingelheim Investigational Site
      • Ortez, France
        • 1218.52.3306A Boehringer Ingelheim Investigational Site
      • Orthez, France
        • 1218.52.3306C Boehringer Ingelheim Investigational Site
      • Savonnières, France
        • 1218.52.3302E Boehringer Ingelheim Investigational Site
      • St Martin d'Oney, France
        • 1218.52.3303B Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1218.52.3308A Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1218.52.3308D Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1218.52.3308E Boehringer Ingelheim Investigational Site
      • Toulon, France
        • 1218.52.3307D Boehringer Ingelheim Investigational Site
      • Tours, France
        • 1218.52.3302A Boehringer Ingelheim Investigational Site
  • Germany
      • Bad Dürrheim-Sunthausen, Germany
        • 1218.52.49002 Boehringer Ingelheim Investigational Site
      • Köln, Germany
        • 1218.52.49006 Boehringer Ingelheim Investigational Site
      • München, Germany
        • 1218.52.49003 Boehringer Ingelheim Investigational Site
      • Schauenburg, Germany
        • 1218.52.49007 Boehringer Ingelheim Investigational Site
  • India
      • Aurangabad, India
        • 1218.52.91009 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.52.91001 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.52.91004 Boehringer Ingelheim Investigational Site
      • Bangalore, India
        • 1218.52.91012 Boehringer Ingelheim Investigational Site
      • Bhopal, India
        • 1218.52.91011 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1218.52.91003 Boehringer Ingelheim Investigational Site
      • Chennai, India
        • 1218.52.91020 Boehringer Ingelheim Investigational Site
      • Hyderadad, India
        • 1218.52.91018 Boehringer Ingelheim Investigational Site
      • Jaipur, India
        • 1218.52.91008 Boehringer Ingelheim Investigational Site
      • Karnataka, India
        • 1218.52.91002 Boehringer Ingelheim Investigational Site
      • Karnataka, India
        • 1218.52.91007 Boehringer Ingelheim Investigational Site
      • Madurai, India
        • 1218.52.91019 Boehringer Ingelheim Investigational Site
      • Maharashtra, India
        • 1218.52.91013 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 1218.52.91015 Boehringer Ingelheim Investigational Site
      • Nagpru, India
        • 1218.52.91014 Boehringer Ingelheim Investigational Site
      • P.O.Trivandrum, India
        • 1218.52.91016 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1218.52.91010 Boehringer Ingelheim Investigational Site
      • West Bengal, India
        • 1218.52.91006 Boehringer Ingelheim Investigational Site
  • Lithuania
      • Kaunas, Lithuania
        • 1218.52.37001 Boehringer Ingelheim Investigational Site
      • Kaunas, Lithuania
        • 1218.52.37004 Boehringer Ingelheim Investigational Site
      • Vilnius, Lithuania
        • 1218.52.37003 Boehringer Ingelheim Investigational Site
  • Mexico
      • Aguascalientes, Mexico
        • 1218.52.52006 Boehringer Ingelheim Investigational Site
      • Cuernavaca, Mexico
        • 1218.52.52002 Boehringer Ingelheim Investigational Site
      • Guadalajara, Mexico
        • 1218.52.52004 Boehringer Ingelheim Investigational Site
      • Mexico, Mexico
        • 1218.52.52007 Boehringer Ingelheim Investigational Site
      • Mexico, Mexico
        • 1218.52.52008 Boehringer Ingelheim Investigational Site
      • Tijuana, Mexico
        • 1218.52.52010 Boehringer Ingelheim Investigational Site
      • Veracruz, Mexico
        • 1218.52.52009 Boehringer Ingelheim Investigational Site
  • Netherlands
      • 's Hertogenbosch, Netherlands
        • 1218.52.31004 Boehringer Ingelheim Investigational Site
      • 's Hertogenbosch, Netherlands
        • 1218.52.31005 Boehringer Ingelheim Investigational Site
      • Almere, Netherlands
        • 1218.52.31001 Boehringer Ingelheim Investigational Site
      • Beek en Donk, Netherlands
        • 1218.52.31002 Boehringer Ingelheim Investigational Site
      • Breda, Netherlands
        • 1218.52.31010 Boehringer Ingelheim Investigational Site
      • Groningen, Netherlands
        • 1218.52.31013 Boehringer Ingelheim Investigational Site
      • Velp, Netherlands
        • 1218.52.31014 Boehringer Ingelheim Investigational Site
      • Zoetermeer, Netherlands
        • 1218.52.31015 Boehringer Ingelheim Investigational Site
  • Romania
      • Alba Iulia, Romania
        • 1218.52.40001 Boehringer Ingelheim Investigational Site
      • Galati, Romania
        • 1218.52.40005 Boehringer Ingelheim Investigational Site
      • Oradea, Romania
        • 1218.52.40003 Boehringer Ingelheim Investigational Site
      • Ploiesti, Romania
        • 1218.52.40002 Boehringer Ingelheim Investigational Site
      • Satu Mare, Romania
        • 1218.52.40004 Boehringer Ingelheim Investigational Site
  • Russian Federation
      • Moscow, Russian Federation
        • 1218.52.70001 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.52.70002 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.52.70003 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.52.70004 Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • 1218.52.70006 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.52.70005 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Russian Federation
        • 1218.52.70007 Boehringer Ingelheim Investigational Site
  • Sweden
      • Goteborg, Sweden
        • 1218.52.46002 Boehringer Ingelheim Investigational Site
      • Malmo, Sweden
        • 1218.52.46003 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1218.52.46005 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 1218.52.46001 Boehringer Ingelheim Investigational Site
  • Tunisia
      • Bab Saâdoun Tunis, Tunisia
        • 1218.52.2162A Boehringer Ingelheim Investigational Site
      • Bab Sâadoun Tunis, Tunisia
        • 1218.52.2162B Boehringer Ingelheim Investigational Site
      • Bab Sâadoun Tunis, Tunisia
        • 1218.52.9992 Boehringer Ingelheim Investigational Site
      • Tunis, Tunisia
        • 1218.52.2161A Boehringer Ingelheim Investigational Site
      • Tunis, Tunisia
        • 1218.52.2161B Boehringer Ingelheim Investigational Site
      • Tunis, Tunisia
        • 1218.52.2163A Boehringer Ingelheim Investigational Site
      • Tunis, Tunisia
        • 1218.52.2163B Boehringer Ingelheim Investigational Site
      • Tunis, Tunisia
        • 1218.52.9991 Boehringer Ingelheim Investigational Site
      • Tunis, Tunisia
        • 1218.52.9993 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Kiev, Ukraine
        • 1218.52.38003 Boehringer Ingelheim Investigational Site
      • Lviv, Ukraine
        • 1218.52.38001 Boehringer Ingelheim Investigational Site
      • Lvov, Ukraine
        • 1218.52.38005 Boehringer Ingelheim Investigational Site
      • Odessa, Ukraine
        • 1218.52.38002 Boehringer Ingelheim Investigational Site
      • Odessa, Ukraine
        • 1218.52.38004 Boehringer Ingelheim Investigational Site
      • Vinnitsa, Ukraine
        • 1218.52.38006 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Linagliptin + metformin bid
Linagliptin low dose + metformin 500 mg, bid
Drug: Linagliptin + metformin
Linagliptin tablet low dose + metformin tablet 500 mg bid
EXPERIMENTAL: Linagliptin+ metformin bid
Linagliptin low dose + metformin 1000 mg bid
Drug: Linagliptin+metformin
Linagliptin low dose tablet + metformin 1000 mg tablet bid
ACTIVE_COMPARATOR: Metformin bid
Metformin 1000 mg bid
Drug: Metformin
Metformin 1000 mg tablet bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Patients With Adverse Events (AEs)
Time Frame: 54 weeks
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)
Time Frame: 54 weeks
Baseline is defined as Visit 1 of 1218.52.
54 weeks
Change From Baseline at Week 54 in Pulse Rate
Time Frame: 54 weeks
Baseline is defined as Visit 1 of 1218.52.
54 weeks
Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology
Time Frame: 54 weeks
54 weeks
Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry
Time Frame: 54 weeks
ULN means upper limit of normal
54 weeks
Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE
Time Frame: Baseline and drug stop (up to 54 weeks) + 7 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline Over Time
Time Frame: 54 weeks
HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52.
54 weeks
Number of Patients With HbA1c <7.0% After 54 Weeks
Time Frame: 54 weeks
54 weeks
Number of Patients With HbA1c <6.5% Over Time
Time Frame: 54 weeks
54 weeks
Number of Patients With HbA1c of at Least <0.5% Over Time
Time Frame: 54 weeks
54 weeks
Change in FPG From Baseline Over Time
Time Frame: 54 weeks
Baseline is defined as visit 1 of 1218.52.
54 weeks
Number of Patients With Rescue Therapy
Time Frame: 54 weeks
54 weeks
Change in HbA1c From Baseline Over Time
Time Frame: 78 weeks
HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).
78 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (ESTIMATE)

June 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2014

Last Update Submitted That Met QC Criteria

April 29, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.52
  • 2008-008494-59 (EUDRACT_NUMBER: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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