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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
567
Linagliptin tablet low dose + metformin tablet 500 mg bid
Linagliptin low dose tablet + metformin 1000 mg tablet bid
Metformin 1000 mg tablet bid
Frequency of Patients With Adverse Events (AEs)
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Time frame: 54 weeks
Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Baseline is defined as Visit 1 of 1218.52.
Time frame: 54 weeks
Change From Baseline at Week 54 in Pulse Rate
Baseline is defined as Visit 1 of 1218.52.
Time frame: 54 weeks
Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology
Time frame: 54 weeks
Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry
ULN means upper limit of normal
Time frame: 54 weeks
Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE
Frequency of patients with adverse events by treatment, primary system organ class and preferred term
Time frame: Baseline and drug stop (up to 54 weeks) + 7 days
Change in HbA1c From Baseline Over Time
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.
Time frame: 54 weeks
Number of Patients With HbA1c <7.0% After 54 Weeks
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1218.52.11005 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1218.52.11003 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1218.52.11002 Boehringer Ingelheim Investigational Site
Red Deer, Alberta, Canada
1218.52.11006 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1218.52.11008 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
1218.52.11004 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1218.52.11007 Boehringer Ingelheim Investigational Site
Oakville, Ontario, Canada
1218.52.11010 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1218.52.38502 Boehringer Ingelheim Investigational Site
Karlovac, Croatia
1218.52.38503 Boehringer Ingelheim Investigational Site
Krapinske Toplice, Croatia
...and 102 more locations
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
Baseline is defined as visit 1 of 1218.52.
Time frame: 54 weeks
Number of Patients With Rescue Therapy
Time frame: 54 weeks
Change in HbA1c From Baseline Over Time
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).
Time frame: 78 weeks