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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00915772
First received: June 2, 2009
Last updated: April 29, 2014
Last verified: April 2014
History of Changes

June 2, 2009
April 29, 2014
June 2009
June 2011   (final data collection date for primary outcome measure)
  • Frequency of Patients With Adverse Events (AEs) [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Baseline is defined as Visit 1 of 1218.52.
  • Change From Baseline at Week 54 in Pulse Rate [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    Baseline is defined as Visit 1 of 1218.52.
  • Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Frequency of patients with adverse events by treatment, primary system organ class and preferred term
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 ]
Complete list of historical versions of study NCT00915772 on ClinicalTrials.gov Archive Site
  • Change in HbA1c From Baseline Over Time [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Patients With HbA1c <6.5% Over Time [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • Number of Patients With HbA1c of at Least <0.5% Over Time [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • Change in FPG From Baseline Over Time [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
    Baseline is defined as visit 1 of 1218.52.
  • Number of Patients With Rescue Therapy [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c From Baseline Over Time [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
    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).
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 ]
Not Provided
Not Provided
 
Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
567
Not Provided
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Croatia,   Estonia,   France,   Germany,   India,   Lithuania,   Mexico,   Netherlands,   Romania,   Russian Federation,   Sweden,   Tunisia,   Ukraine
 
NCT00915772
1218.52, 2008-008494-59
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP