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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342484
• Other study ID #: 1218.56
• Secondary ID: 2009-017004-91
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2011
• Last updated: February 16, 2016
• Start date: April 2011
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Guatemala: Ministry of Public Health and Social AssistanceItaly: Ethics CommitteeMexico: Federal Commission for Protection Against Health RisksPoland: Registration Medicinal Product Medical Device Biocidal ProductRussia: Pharmacological Committee, Ministry of HealthSouth Korea: Ministry of Food and Drug Safety (MFDS)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• placebo
comparison of different dosages of drug (low vs high) vs placebo
• BI1356 low dose
comparison of different dosages of drug (low vs high) vs placebo
• BI1356 high dose
comparison of different dosages of drug (low vs high) vs placebo

Locations

Country	Name	City	State
Canada	1218.56.11001 Boehringer Ingelheim Investigational Site	Montreal	Quebec
France	1218.56.33003 Boehringer Ingelheim Investigational Site	Fort de France cedex
France	1218.56.33002 Boehringer Ingelheim Investigational Site	Lille
France	1218.56.33005 Boehringer Ingelheim Investigational Site	Reims
France	1218.56.33006 Boehringer Ingelheim Investigational Site	Rouen
France	1218.56.33008 Boehringer Ingelheim Investigational Site	Saint Denis Cedex
France	1218.56.33009 Boehringer Ingelheim Investigational Site	SAINT PIERRE Cedex
Guatemala	1218.56.50202 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1218.56.50203 Boehringer Ingelheim Investigational Site	Guatemala
Italy	1218.56.39001 Boehringer Ingelheim Investigational Site	Chieti
Italy	1218.56.39005 Boehringer Ingelheim Investigational Site	Firenze
Italy	1218.56.39006 Boehringer Ingelheim Investigational Site	Messina
Italy	1218.56.39007 Boehringer Ingelheim Investigational Site	Palermo
Korea, Republic of	1218.56.82005 Boehringer Ingelheim Investigational Site	Busan
Korea, Republic of	1218.56.82001 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1218.56.82002 Boehringer Ingelheim Investigational Site	Seoul
Korea, Republic of	1218.56.82003 Boehringer Ingelheim Investigational Site	Suwon
Mexico	1218.56.52008 Boehringer Ingelheim Investigational Site	Chihuahua
Mexico	1218.56.52002 Boehringer Ingelheim Investigational Site	Guadalajara
Mexico	1218.56.52001 Boehringer Ingelheim Investigational Site	León
Mexico	1218.56.52003 Boehringer Ingelheim Investigational Site	Monterrey
Mexico	1218.56.52004 Boehringer Ingelheim Investigational Site	Oaxaca
Poland	1218.56.48002 Boehringer Ingelheim Investigational Site	Gdansk
Poland	1218.56.48001 Boehringer Ingelheim Investigational Site	Gliwice
Poland	1218.56.48004 Boehringer Ingelheim Investigational Site	Warszawa
Poland	1218.56.48003 Boehringer Ingelheim Investigational Site	Wroclaw
Russian Federation	1218.56.70001 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1218.56.70003 Boehringer Ingelheim Investigational Site	Saratov
Russian Federation	1218.56.70004 Boehringer Ingelheim Investigational Site	Ufa
Russian Federation	1218.56.70006 Boehringer Ingelheim Investigational Site	Yekaterinburg
United States	1218.56.01004 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	1218.56.01006 Boehringer Ingelheim Investigational Site	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  France,  Guatemala,  Italy,  Korea, Republic of,  Mexico,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint in this trial is the change from baseline in Glycosylated Haemoglobin (HbA1c) (%) after 12 weeks of treatment		12 weeks	No
Secondary	The secondary efficacy endpoint is the change from baseline in fasting plasma glucose (mmol/L) after 12 weeks of treatment		12 weeks	No
Secondary	The key secondary endpoint in this trial is DPP-4 inhibition (%) at trough at steady state		4 weeks or 8 weeks or 12 weeks	No