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

Tracking Information
First Submitted Date ICMJE	June 2, 2009
First Posted Date ICMJE	June 8, 2009
Results First Submitted Date	June 13, 2012
Results First Posted Date	July 18, 2012
Last Update Posted Date	May 14, 2014
Study Start Date ICMJE	June 2009
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 11, 2013)	Frequency of Patients With Adverse Events (AEs) [ Time Frame: 54 weeks ]This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.; 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.; Change From Baseline at Week 54 in Pulse Rate [ Time Frame: 54 weeks ]Baseline is defined as Visit 1 of 1218.52.; Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology [ Time Frame: 54 weeks ]; Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry [ Time Frame: 54 weeks ]ULN means upper limit of normal; 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
Original 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 ]
Change History	Complete list of historical versions of study NCT00915772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 13, 2012)	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.; Number of Patients With HbA1c <7.0% After 54 Weeks [ Time Frame: 54 weeks ]; Number of Patients With HbA1c <6.5% Over Time [ Time Frame: 54 weeks ]; Number of Patients With HbA1c of at Least <0.5% Over Time [ Time Frame: 54 weeks ]; Change in FPG From Baseline Over Time [ Time Frame: 54 weeks ]Baseline is defined as visit 1 of 1218.52.; Number of Patients With Rescue Therapy [ Time Frame: 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).
Original 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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
Official Title ICMJE	Extension 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	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Diabetes Mellitus, Type 2
Intervention ICMJE	Drug: Linagliptin + metformin Linagliptin tablet low dose + metformin tablet 500 mg bid; Drug: Linagliptin+metformin Linagliptin low dose tablet + metformin 1000 mg tablet bid; Drug: Metformin Metformin 1000 mg tablet bid
Study Arms	Experimental: Linagliptin + metformin bid Linagliptin low dose + metformin 500 mg, bid Intervention: Drug: Linagliptin + metformin; Experimental: Linagliptin+ metformin bid Linagliptin low dose + metformin 1000 mg bid Intervention: Drug: Linagliptin+metformin; Active Comparator: Metformin bid Metformin 1000 mg bid Intervention: Drug: Metformin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 14, 2010)	567
Original Estimated Enrollment ICMJE; (submitted: June 5, 2009)	700
Study Completion Date	Not Provided
Actual Primary Completion Date	June 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, Croatia, Estonia, France, Germany, India, Lithuania, Mexico, Netherlands, Romania, Russian Federation, Sweden, Tunisia, Ukraine
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00915772
Other Study ID Numbers ICMJE	1218.52; 2008-008494-59 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Boehringer Ingelheim
Study Sponsor ICMJE	Boehringer Ingelheim
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account	Boehringer Ingelheim
Verification Date	April 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP