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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: April 24, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the plasma concentration vs. time curve [ Time Frame: within dosing interval ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin [ Time Frame: throughout study duration (pre-, during and post-treatment) ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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 Clinical Trial Call Center
Los Angeles, California, United States, 90036
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Aurora, Colorado, United States, 80045
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Iowa City, Iowa, United States, 52242
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40202
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45229
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38105
Belgium
Brussels, Belgium, 1090
Slovenia
Ljubljana, Slovenia, 1525
United Kingdom
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: D J Chatterjee, Ph.D. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00943501     History of Changes
Other Study ID Numbers: NN2211-1800, U1111-1111-9256, 2010-021057-39
Study First Received: July 21, 2009
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration
Slovenia: Agency for Medicinal Products - Ministry of Health
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon-Like Peptide 1
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014