The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,263
Placebo, identical to Linagliptin tablet
intended final marketed dose
Change From Baseline in HbA1c After 24 Weeks
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Time frame: Baseline and 24 weeks
Number of Patients With HbA1c < 7.0 Percent
Time frame: 24 and 52 weeks
Number of Patients Lowering HbA1c by at Least 0.5 Percent
Time frame: 24 and 52 weeks
Change From Baseline in HbA1c by Visit at Week 6
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time frame: Baseline and 6 weeks
Change From Baseline in HbA1c by Visit at Week 12
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time frame: Baseline and 12 weeks
Change From Baseline in HbA1c by Visit at Week 18
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time frame: Baseline and 18 weeks
Change From Baseline in HbA1c by Visit at Week 32
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time frame: Baseline and 32 weeks
Change From Baseline in HbA1c by Visit at Week 40
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
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1218.36.01043 Boehringer Ingelheim Investigational Site
Escondido, California, United States
1218.36.01051 Boehringer Ingelheim Investigational Site
Escondido, California, United States
1218.36.01065 Boehringer Ingelheim Investigational Site
Fresno, California, United States
1218.36.01021 Boehringer Ingelheim Investigational Site
Greenbrae, California, United States
1218.36.01013 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1218.36.01048 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1218.36.01058 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1218.36.01008 Boehringer Ingelheim Investigational Site
Santa Ana, California, United States
1218.36.01056 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
1218.36.01054 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
...and 159 more locations
Time frame: Baseline and 40 weeks
Change From Baseline in HbA1c by Visit at Week 52
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time frame: Baseline and 52 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment
Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
Time frame: Baseline and 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Change From Baseline in FPG
Time frame: Baseline, 6, 12, 18, 24, 32 and 40 weeks
Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment
Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
Time frame: Baseline and 52 weeks
Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment
Mean Daily Glucose was calculated using the 8-point blood glucose profile
Time frame: Baseline, 24 and 52 weeks
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment
Time frame: Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner