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
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Linagliptin + metformin
Drug: Linagliptin+metformin
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Enrollment: 567
Study Start Date: June 2009
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915772

  Show 112 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00915772     History of Changes
Other Study ID Numbers: 1218.52, 2008-008494-59
Study First Received: June 2, 2009
Results First Received: June 13, 2012
Last Updated: April 29, 2014
Health Authority: Canada: Health Canada
Croatia: Agency for Medicinal Product and Medical Devices
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Sweden: Regional Ethical Review Board
Tunisia: Ministry of Public Health
Ukraine: State Pharmacological Center - Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Linagliptin
Metformin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014