CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01342484
NCT01342484Phase 2Completed
CompareCT.gov

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

Boehringer Ingelheim·interventional·Posted Apr 27, 2011·Updated Sep 15, 2016

In Brief

A Phase 2 clinical trial evaluating placebo, BI1356 low dose, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 40 participants across 25 sites in 9 countries.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCanada, France, Guatemala, Italy, Mexico, Poland, Russia, South Korea, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2011
Enrollment StartApr 1, 2011
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.2 years ago

Interventions

placebodrug

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

BI1356 low dosedrug

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

BI1356 high dosedrug

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