The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
561
Change From Baseline in HbA1c at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time frame: 12 weeks
Change From Baseline in HbA1c at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time frame: 26 weeks
Examination of Long-term Safety of Linagliptin (52-week Treatment)
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
Time frame: 52 weeks
Relative Efficacy Response of HbA1c at Week 12
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
Time frame: 12 weeks
Relative Efficacy Response of HbA1c at Week 26
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
Time frame: 26 weeks
Relative Efficacy Response of HbA1c at Week 52
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
Time frame: 52 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
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once daily
0.6 mg/daily
1218.23.05 Boehringer Ingelheim Investigational Site
Asahi, Chiba, Japan
1218.23.06 Boehringer Ingelheim Investigational Site
Funabashi, Chiba, Japan
1218.23.21 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki, Japan
1218.23.44 Boehringer Ingelheim Investigational Site
Hitachiota, Ibaraki, Japan
1218.23.09 Boehringer Ingelheim Investigational Site
Imizu, Toyama, Japan
1218.23.45 Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaraki, Japan
1218.23.13 Boehringer Ingelheim Investigational Site
Izumisano, Osaka, Japan
1218.23.27 Boehringer Ingelheim Investigational Site
Kariya, Aichi, Japan
1218.23.47 Boehringer Ingelheim Investigational Site
Kitakatsushika-gun, Saitama, Japan
1218.23.39 Boehringer Ingelheim Investigational Site
Kitakyuushuu, Fukuoka, Japan
...and 37 more locations
Time frame: 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time frame: 26 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time frame: 52 weeks