The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment. Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
comparison of different dosages of drug (low vs high) vs placebo
comparison of different dosages of drug (low vs high) vs placebo
comparison of different dosages of drug (low vs high) vs placebo
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment
Change from baseline in Glycosylated haemoglobin (HbA1c) \[%\] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Time frame: Baseline and 12 weeks
Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State
DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100.
Time frame: Baseline and 4 weeks or 8 weeks or 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment
Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.
Time frame: Baseline and 12 weeks
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1218.56.01006 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1218.56.01004 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
1218.56.11001 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1218.56.33003 Boehringer Ingelheim Investigational Site
Fort de France Cedex, France
1218.56.33006 Boehringer Ingelheim Investigational Site
Rouen, France
1218.56.50202 Boehringer Ingelheim Investigational Site
Guatemala City, Guatemala
1218.56.50203 Boehringer Ingelheim Investigational Site
Guatemala City, Guatemala
1218.56.39005 Boehringer Ingelheim Investigational Site
Florence, Italy
1218.56.52008 Boehringer Ingelheim Investigational Site
Chihuahua City, Mexico
1218.56.52002 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
...and 15 more locations