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

Phase 3

Completed

Interventions: Drug: Linagliptin + metformin
Drug: Linagliptin+metformin
Drug: Metformin

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Linagliptin + metformin bid	Linagliptin + metformin	Linagliptin low dose + metformin 500 mg, bid
Linagliptin+ metformin bid	Linagliptin+metformin	Linagliptin low dose + metformin 1000 mg bid
Metformin bid	Metformin	Metformin 1000 mg bid

Primary Outcome Measures

Name	Time	Method
Frequency of Patients With Adverse Events (AEs)	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)	54 weeks	Baseline is defined as Visit 1 of 1218.52.
Change From Baseline at Week 54 in Pulse Rate	54 weeks	Baseline is defined as Visit 1 of 1218.52.
Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology	54 weeks
Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry	54 weeks	ULN means upper limit of normal
Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE	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 Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline Over Time	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).
Number of Patients With HbA1c <7.0% After 54 Weeks	54 weeks
Number of Patients With HbA1c <6.5% Over Time	54 weeks
Number of Patients With HbA1c of at Least <0.5% Over Time	54 weeks
Change in FPG From Baseline Over Time	54 weeks	Baseline is defined as visit 1 of 1218.52.
Number of Patients With Rescue Therapy	54 weeks

Locations (112): 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
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1218.52.11005 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada