The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
278
Placebo matching linagliptin tablets once daily
Linagliptin tablets once daily
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: baseline, 24 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: baseline, 6 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: baseline, 12 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: baseline, 18 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: 24 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: 24 weeks
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Time frame: 24 weeks
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1218.61.01028 Boehringer Ingelheim Investigational Site
Escondido, California, United States
1218.61.01014 Boehringer Ingelheim Investigational Site
Greenbrae, California, United States
1218.61.01015 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1218.61.01042 Boehringer Ingelheim Investigational Site
Paramount, California, United States
1218.61.01046 Boehringer Ingelheim Investigational Site
Poway, California, United States
1218.61.01044 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1218.61.01009 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1218.61.01049 Boehringer Ingelheim Investigational Site
Lawrenceville, Georgia, United States
1218.61.01008 Boehringer Ingelheim Investigational Site
Roswell, Georgia, United States
1218.61.01040 Boehringer Ingelheim Investigational Site
Meridian, Idaho, United States
...and 42 more locations
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24
Time frame: baseline, 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6
Time frame: baseline, 6 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12
Time frame: baseline, 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks
Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18
Time frame: baseline, 18 weeks