Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00943501
• Collaborator: (none)
• Enrollment: 21
• Locations: 20
• Arms: 4
• Duration (Months): 22
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of multiple doses of liraglutide in the pediatric population (children).

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: liraglutide; Drug: placebo; Drug: liraglutide; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Liraglutide: A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Pediatric (10-17 Years Old) With Type 2 Diabetes
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I.a	Drug: liraglutide; Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
Placebo Comparator: I.b	Drug: placebo; Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
Experimental: II.a	Drug: liraglutide; Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
Placebo Comparator: II.b	Drug: placebo; Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).

Outcome Measures

Primary Outcome Measures

1. Number and type of adverse events [up to 8 weeks]

Secondary Outcome Measures

1. Pharmacokinetics: Area under the plasma concentration vs. time curve [within dosing interval]

2. Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin [throughout study duration (pre-, during and post-treatment)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• BMI greater than 85th percentile for age and gender

• Currently being treated with diet and exercise or metformin alone

• HbA1c (glycosylated haemoglobin) between 6.5 and 11.0%

Exclusion Criteria:

• Any clinically significant disease other than type 2 diabetes, as judged by the trial physician

• Previous treatment with any anti-diabetic drug other than metformin (except for prior short term treatment, at the discretion of the trial physician)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Cypress	California	United States	90630
2	Novo Nordisk Investigational Site	Los Angeles	California	United States	90036
3	Novo Nordisk Investigational Site	Los Angeles	California	United States	90048-1869
4	Novo Nordisk Investigational Site	Aurora	Colorado	United States	80045
5	Novo Nordisk Investigational Site	Iowa City	Iowa	United States	52242
6	Novo Nordisk Investigational Site	Louisville	Kentucky	United States	40202
7	Novo Nordisk Investigational Site	Kansas City	Missouri	United States	64108-4619
8	Novo Nordisk Investigational Site	Cincinnati	Ohio	United States	45229
9	Novo Nordisk Investigational Site	Cleveland	Ohio	United States	44106
10	Novo Nordisk Investigational Site	Toledo	Ohio	United States	43606
11	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104
12	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15224
13	Novo Nordisk Investigational Site	Memphis	Tennessee	United States	38103-2800
14	Novo Nordisk Investigational Site	Dallas	Texas	United States	75235
15	Novo Nordisk Investigational Site	Brussels		Belgium	1090
16	Novo Nordisk Investigational Site	Ljubljana		Slovenia	1525
17	Novo Nordisk Investigational Site	Birmingham		United Kingdom	B4 6NH
18	Novo Nordisk Investigational Site	Manchester		United Kingdom	M13 9WL
19	Novo Nordisk Investigational Site	Nottingham		United Kingdom	NG7 2UH
20	Novo Nordisk Investigational Site	Sheffield		United Kingdom	S102TH

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00943501
• Other Study ID Numbers: NN2211-1800; U1111-1111-9256; 2010-021057-39
• First Posted: Jul 22, 2009
• Last Update Posted: Jan 26, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Liraglutide

Study Results

No Results Posted as of Jan 26, 2017