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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI1356 high dose; Drug: BI1356 low dose; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342484

2009-017004-91 (EudraCT Number)

1218.56

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups, including a placebo group

linagliptin low dose

Experimental group

Description:

linagliptin low dose for children once daily

Treatment:

Drug: BI1356 low dose

linagliptin high dose

Experimental group

Description:

linagliptin high dose for children once daily

Treatment:

Drug: BI1356 high dose

placebo

Placebo Comparator group

Description:

matching placebo for each linagliptin dose once daily

Treatment:

Drug: placebo