Clinical trial NCT01342484: Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2011-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State
timeFrame: Baseline and 4 weeks or 8 weeks or 12 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: 1218.56.01006 Boehringer Ingelheim Investigational Site
state: Texas
city: Norfolk
country: United States
facility: 1218.56.01004 Boehringer Ingelheim Investigational Site
state: Virginia
city: Montreal
country: Canada
facility: 1218.56.11001 Boehringer Ingelheim Investigational Site
state: Quebec
city: Fort de France cedex
country: France
facility: 1218.56.33003 Boehringer Ingelheim Investigational Site
city: Rouen
country: France
facility: 1218.56.33006 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1218.56.50202 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1218.56.50203 Boehringer Ingelheim Investigational Site
city: Firenze
country: Italy
facility: 1218.56.39005 Boehringer Ingelheim Investigational Site
city: Busan
country: Korea, Republic of
facility: 1218.56.82005 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1218.56.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1218.56.82002 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1218.56.82003 Boehringer Ingelheim Investigational Site
city: Chihuahua
country: Mexico
facility: 1218.56.52008 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1218.56.52002 Boehringer Ingelheim Investigational Site
city: León
country: Mexico
facility: 1218.56.52001 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1218.56.52003 Boehringer Ingelheim Investigational Site
city: Oaxaca
country: Mexico
facility: 1218.56.52004 Boehringer Ingelheim Investigational Site
city: Gdansk
country: Poland
facility: 1218.56.48002 Boehringer Ingelheim Investigational Site
city: Gliwice
country: Poland
facility: 1218.56.48001 Boehringer Ingelheim Investigational Site
city: Warszawa
country: Poland
facility: 1218.56.48004 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1218.56.48003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.56.70001 Boehringer Ingelheim Investigational Site
city: Saratov
country: Russian Federation
facility: 1218.56.70003 Boehringer Ingelheim Investigational Site
city: Ufa
country: Russian Federation
facility: 1218.56.70004 Boehringer Ingelheim Investigational Site
city: Yekaterinburg
country: Russian Federation
facility: 1218.56.70006 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: