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:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00915772
First received: June 2, 2009
Last updated: February 13, 2013
Last verified: February 2013
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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 Pharmaceuticals:
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915772
Show 112 Study Locations
Show 112 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| 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: | February 13, 2013 |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases BI 1356 Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013