A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus
- NCT01342484
- PHASE2
- INTERVENTIONAL
Last updated: 2016-09-15
Purpose of Trial
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.
This study is for people with
Diabetes Mellitus, Type 2
Interventions being studied
placebo
BI1356 low dose
BI1356 high dose
Inclusion criteria:
1. Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus
2. Insufficient glycaemic control (i.e. an HbA1c \> 6.5% and \<= 10.5%) despite treatment with diet and exercise and/or metformin (\>= 1000 mg per day (or the maximum tolerated dose) at a stable dose or dosing frequency for 8 weeks prior to randomisation) and/or concomitant stable basal insulin (total daily dose must be \<= 0.5U/kg with less than 10% of weekly dose change for 12 weeks prior to randomisation)
3. Negative for islet cell antigen (ICA) auto-antibodies and glutamic acid decarboxylase (GAD) auto-antibodies
4. C-peptide levels (serum) \>= 1.5 ng/ml (at 90 min following a Boost challenge)
Exclusion criteria:
1. History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months
2. Current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation
3. Treatment with weight reduction medications (including anti-obesity treatments)
ELIGIBILITY
Gender: ALL
Age: 10+
Healthy Volunteers: No
2 Locations
San Antonio
1218.56.01006 Boehringer Ingelheim Investigational Site
Texas, United States
Norfolk
1218.56.01004 Boehringer Ingelheim Investigational Site
Virginia, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov