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Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00943501
First received: July 21, 2009
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number and type of adverse events [ Time Frame: up to 8 weeks ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the plasma concentration vs. time curve [ Time Frame: within dosing interval ]
  • Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin [ Time Frame: throughout study duration (pre-, during and post-treatment) ]

Enrollment: 21
Study Start Date: November 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943501

Locations
United States, California
Novo Nordisk Investigational Site
Cypress, California, United States, 90630
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90036
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90048-1869
United States, Colorado
Novo Nordisk Investigational Site
Aurora, Colorado, United States, 80045
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40202
United States, Missouri
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64108-4619
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45229
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44106
Novo Nordisk Investigational Site
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38103-2800
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75235
Belgium
Novo Nordisk Investigational Site
Brussels, Belgium, 1090
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1525
United Kingdom
Novo Nordisk Investigational Site
Birmingham, United Kingdom, B4 6NH
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 9WL
Novo Nordisk Investigational Site
Nottingham, United Kingdom, NG7 2UH
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
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00943501     History of Changes
Other Study ID Numbers: NN2211-1800
U1111-1111-9256 ( Other Identifier: WHO )
2010-021057-39 ( EudraCT Number )
Study First Received: July 21, 2009
Last Updated: January 25, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on March 24, 2017