Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
876
linagliptin2.5mg/metformin1000mg BID
linagliptin2.5mg/metformin1000mg BID
linagliptin 5mg once daily
The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group
The change from baseline in HbA1c after 24 weeks of treatment in main group. The mean was adjusted by baseline HbA1c and treatment group.
Time frame: Baseline and week 24
The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)
The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases \[OC\]) were considered. The mean was adjusted by treatment, baseline HbA1c, week and treatment\*week. The sensitivity analysis was added as the primary analysis failed with borderline results.
Time frame: Baseline and week 24
The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG
The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG) The mean was adjusted by baseline HbA1c and treatment group.
Time frame: Baseline and week 12
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group
The occurrence of treat to target efficacy response in terms of HbA1c \< 7.0 % after 24 weeks of treatment in main group.
Time frame: Week 24 (after first drug administration)
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG
The occurrence of treat to target efficacy response in terms of HbA1c \< 7.0 % after 12 weeks of treatment in APG.
Time frame: Week 12 (after first drug administration)
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Metformin 500mg BID
linagliptin2.5mg/metformin500mg BID
linagliptin2.5mg/metformin500mg BID
linagliptin 5mg once daily
Metformin 1000mg BID
1288.18.86001 Boehringer Ingelheim Investigational Site
Beijing, China
1288.18.86002 Boehringer Ingelheim Investigational Site
Beijing, China
1288.18.86003 Boehringer Ingelheim Investigational Site
Beijing, China
1288.18.86004 Boehringer Ingelheim Investigational Site
Beijing, China
1288.18.86046 Boehringer Ingelheim Investigational Site
Beijing, China
1288.18.86019 Boehringer Ingelheim Investigational Site
Changchun, China
1288.18.86020 Boehringer Ingelheim Investigational Site
Changchun, China
1288.18.86028 Boehringer Ingelheim Investigational Site
Changsha, China
1288.18.86029 Boehringer Ingelheim Investigational Site
Changsha, China
1288.18.86050 Boehringer Ingelheim Investigational Site
Changsha, China
...and 46 more locations
The occurrence of treat to target efficacy response in terms of HbA1c \< 6.5% after 24 weeks of treatment in main group.
Time frame: Week 24 (after first drug administration)
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG
The occurrence of treat to target efficacy response in terms of HbA1c \< 6.5% after 12 weeks of treatment in APG.
Time frame: Week 12 (after first drug administration)
The Occurrence of Relative Efficacy Response in Main Group
The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group
Time frame: From baseline until week 24
The Occurrence of Relative Efficacy Response in APG
The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG
Time frame: From baseline until week 12
The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group
The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group. Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.
Time frame: Baseline and week 24
The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG
The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG. Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.
Time frame: Baseline and week 12
The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group
The frequency of patients with use of rescue therapy during 24 week treatment period in main group. For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group.
Time frame: From baseline until week 24
The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG
The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.
Time frame: From baseline until week 12