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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 40
- Locations
- 25
- Primary Endpoint
- Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
linagliptin low dose
linagliptin low dose for children once daily
Intervention: BI1356 low dose (Drug)
linagliptin high dose
linagliptin high dose for children once daily
Intervention: BI1356 high dose (Drug)
placebo
matching placebo for each linagliptin dose once daily
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
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.
Secondary Outcomes
- Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State(Baseline and 4 weeks or 8 weeks or 12 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment(Baseline and 12 weeks)