Phase 2 Completed N=39 Randomized Double-blind Treatment

Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes

Source: ClinicalTrials.gov NCT01342484 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Sep 2016

Primary outcomePrimary: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment — 0.45; -0.03; -0.19 Percentage of HbA1c — p=0.3295

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment	0.45; -0.03; -0.19	0.3295
SECONDARY Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State	38.4; 78.9	—
SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment	1.70; 1.39; -0.19	0.8216

Eligibility Criteria

Inclusion criteria

Paediatric patients (children and adolescents), aged 10 to 17 years with documented diagnosis of type 2 diabetes mellitus
Insufficient glycaemic control (i.e. an HbA1c > 6.5% and = 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 = 1.5 ng/ml (at 90 min following a Boost challenge)

Exclusion criteria

History of acute metabolic decompensation, such as diabetic ketoacidosis, within 3 months
Current short-acting insulin or having received short-acting insulin for more than 3 days within 1 month prior to randomisation
Treatment with weight reduction medications (including anti-obesity treatments)

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Data sourced from ClinicalTrials.gov (NCT01342484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.