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

NCT01342484 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-15

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

placebo

comparison of different dosages of drug (low vs high) vs placebo

DRUG

BI1356 low dose

comparison of different dosages of drug (low vs high) vs placebo

DRUG

BI1356 high dose

comparison of different dosages of drug (low vs high) vs placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States
  • Canada
  • France
  • Guatemala
  • Italy
  • Mexico
  • Poland
  • Russia
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01342484 on ClinicalTrials.gov