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OpenTrials
Completed

NCT Number: NCT00915772

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.52.11005 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linagliptin + metformin

Drug

Linagliptin tablet low dose + metformin tablet 500 mg bid

Linagliptin+metformin

Drug

Linagliptin low dose tablet + metformin 1000 mg tablet bid

metformin

Drug

Metformin 1000 mg tablet bid

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
First posted
Jun 8, 2009
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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