Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | April 2011 |
| End Date: | February 2016 |
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
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.
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.
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)
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