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


Tracking Information

Start Date  ICMJEJune 2009
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: June 5, 2009)		Incidence and intensity of AEs; Withdrawal due to AEs; Clinically relevant new or worsening findings in physical examination and 12lead ECG as reported as AE; Changes from baseline in vital signs and clinical laboratory assessments [ Time Frame: 54 weeks ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00915772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 5, 2009)		Change from baseline in HbA1c and FPG after 54 weeks of treatment and FPG by visit over time; Occurrance of a treat to target response that is an HbA1c under treatment of <7% and < 6.5% after 54 weeks of treatment; HbA1c reduction [ Time Frame: 54 weeks ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJETreatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
Official Title  ICMJEExtension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid
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

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: linagliptin
  • Drug: metformin

Recruitment Information

Estimated Enrollment  ICMJE745
Completion Date 
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study Coordinator1-800-243-0127clintriage.rdg@boehringer-ingelheim.com
Location Countries  ICMJECanada,   Croatia,   Estonia,   France,   Germany,   India,   Lithuania,   Mexico,   Netherlands,   Romania,   Russian Federation,   Sweden,   Tunisia,   Ukraine

Administrative Information

NCT ID  ICMJENCT00915772
Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE1218.52, EudraCT2008-008494-59
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals