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COMPLETEDPHASE2

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

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

NCT01342484•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

10 - 17 years

Sex

ALL

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)

Locations (25)

1218.56.01006 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

1218.56.01004 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

1218.56.11001 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1218.56.33003 Boehringer Ingelheim Investigational Site

Fort de France Cedex, France

1218.56.33006 Boehringer Ingelheim Investigational Site

Rouen, France

1218.56.50202 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

1218.56.50203 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

1218.56.39005 Boehringer Ingelheim Investigational Site

Florence, Italy

1218.56.52008 Boehringer Ingelheim Investigational Site

Chihuahua City, Mexico

1218.56.52002 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Key Dates

Start Date

April 1, 2011

Primary Completion Date

February 1, 2016

Completion Date

February 1, 2016

Last Updated

September 15, 2016

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

placebo

DRUG

BI1356 low dose

DRUG

BI1356 high dose

DRUG

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Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

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