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
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Linagliptin + metformin Drug: Linagliptin+metformin Drug: Metformin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||567 participants|
|Intervention Model:||Single Group Assignment|
|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|
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
Linagliptin low dose tablet + metformin 1000 mg tablet bid
Active Comparator: Metformin bid
Metformin 1000 mg bid
Metformin 1000 mg tablet bid
- Frequency of Patients With Adverse Events (AEs) [ Time Frame: 54 weeks ]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 ]Baseline is defined as Visit 1 of 1218.52.
- Change From Baseline at Week 54 in Pulse Rate [ Time Frame: 54 weeks ]Baseline is defined as Visit 1 of 1218.52.
- Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology [ Time Frame: 54 weeks ]
- Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry [ Time Frame: 54 weeks ]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 ]Frequency of patients with adverse events by treatment, primary system organ class and preferred term
- 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.
- Number of Patients With HbA1c <7.0% After 54 Weeks [ Time Frame: 54 weeks ]
- Number of Patients With HbA1c <6.5% Over Time [ Time Frame: 54 weeks ]
- Number of Patients With HbA1c of at Least <0.5% Over Time [ Time Frame: 54 weeks ]
- Change in FPG From Baseline Over Time [ Time Frame: 54 weeks ]Baseline is defined as visit 1 of 1218.52.
- Number of Patients With Rescue Therapy [ Time Frame: 54 weeks ]
- 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).
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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|
- 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)
- 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
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
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|
|Responsible Party:||Boehringer Ingelheim|
|Other Study ID Numbers:||
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|
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action