The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
491
patient to receive tablets containing low dose linagliptin twice daily
patient to receive placebo tablet(s) matching linagliptin
patient to receive a tablet containing medium dose linagliptin once daily
HbA1c Change From Baseline at Week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.
Time frame: Baseline and week 12
HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Time frame: Baseline and week 6
HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Time frame: Baseline and week 12
FPG Change From Baseline at Week 12
Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.
Time frame: Baseline and week 12
FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Time frame: Baseline and week 6
FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
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1218.62.32003 Boehringer Ingelheim Investigational Site
De Pinte, Belgium
1218.62.32008 Boehringer Ingelheim Investigational Site
Kortenaken, Belgium
1218.62.32009 Boehringer Ingelheim Investigational Site
Kumtich, Belgium
1218.62.32005 Boehringer Ingelheim Investigational Site
Massemen-Wetteren, Belgium
1218.62.32004 Boehringer Ingelheim Investigational Site
Natoye, Belgium
1218.62.32007 Boehringer Ingelheim Investigational Site
Sint-Job-in't-Goor, Belgium
1218.62.32002 Boehringer Ingelheim Investigational Site
Tessenderlo, Belgium
1218.62.32006 Boehringer Ingelheim Investigational Site
Wilsele, Belgium
1218.62.11012 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1218.62.11007 Boehringer Ingelheim Investigational Site
Burnaby, British Columbia, Canada
...and 74 more locations
Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Time frame: Baseline and week 12
Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12
Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.
Time frame: Week 12
Percentage of Patients With Rescue Therapy
Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.
Time frame: 12 weeks
The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment
Percentage of those patients with baseline HbA1c \>= 7.0% who had HbA1c \< 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
Time frame: 12 weeks
The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment
Percentage of those patients with baseline HbA1c \>= 6.5% who had HbA1c \< 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.
Time frame: 12 weeks