Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00943501
First received: July 21, 2009
Last updated: June 19, 2012
Last verified: June 2012
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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:
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
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 | |
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| Dallas, Texas, United States, 75390-8527 | |
| Belgium | |
| Brussels, Belgium, 1090 | |
| Slovenia | |
| Ljubljana, Slovenia, 1525 | |
| United Kingdom | |
| Manchester, United Kingdom, M13 9WL | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | D J Chatterjee, Ph.D. | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, 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: | June 19, 2012 |
| Health Authority: | United States: Food and Drug Administration Slovenia: Agency for Medicinal Products - Ministry of Health United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glucagon-Like Peptide 1 |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013