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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

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ClinicalTrials.gov Identifier: NCT00915772
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : July 18, 2012
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Linagliptin + metformin Drug: Linagliptin+metformin Drug: Metformin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid
Study Start Date : June 2009
Actual Primary Completion Date : June 2011

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of Patients With Adverse Events (AEs) [ Time Frame: 54 weeks ]
    This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.

  2. 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.

  3. Change From Baseline at Week 54 in Pulse Rate [ Time Frame: 54 weeks ]
    Baseline is defined as Visit 1 of 1218.52.

  4. Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology [ Time Frame: 54 weeks ]
  5. Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry [ Time Frame: 54 weeks ]
    ULN means upper limit of normal

  6. 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


Secondary Outcome Measures :
  1. 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.

  2. Number of Patients With HbA1c <7.0% After 54 Weeks [ Time Frame: 54 weeks ]
  3. Number of Patients With HbA1c <6.5% Over Time [ Time Frame: 54 weeks ]
  4. Number of Patients With HbA1c of at Least <0.5% Over Time [ Time Frame: 54 weeks ]
  5. Change in FPG From Baseline Over Time [ Time Frame: 54 weeks ]
    Baseline is defined as visit 1 of 1218.52.

  6. Number of Patients With Rescue Therapy [ Time Frame: 54 weeks ]
  7. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915772


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00915772    
Other Study ID Numbers: 1218.52
2008-008494-59 ( EudraCT Number: EudraCT )
First Posted: June 8, 2009    Key Record Dates
Results First Posted: July 18, 2012
Last Update Posted: May 14, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Linagliptin
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action