Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes
NCT ID: NCT00943501
Last Updated: 2017-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2009-11-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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I.a
liraglutide
Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
I.b
placebo
Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
II.a
liraglutide
Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
II.b
placebo
Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
Interventions
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liraglutide
Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
placebo
Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
liraglutide
Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
placebo
Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
Eligibility Criteria
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Inclusion Criteria
* Currently being treated with diet and exercise or metformin alone
* HbA1c (glycosylated haemoglobin) between 6.5 and 11.0%
Exclusion Criteria
* Previous treatment with any anti-diabetic drug other than metformin (except for prior short term treatment, at the discretion of the trial physician)
10 Years
17 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Cypress, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Aurora, Colorado, United States
Novo Nordisk Investigational Site
Iowa City, Iowa, United States
Novo Nordisk Investigational Site
Louisville, Kentucky, United States
Novo Nordisk Investigational Site
Kansas City, Missouri, United States
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Cleveland, Ohio, United States
Novo Nordisk Investigational Site
Toledo, Ohio, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Brussels, , Belgium
Novo Nordisk Investigational Site
Ljubljana, , Slovenia
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
Novo Nordisk Investigational Site
Manchester, , United Kingdom
Novo Nordisk Investigational Site
Nottingham, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Countries
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References
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Klein DJ, Battelino T, Chatterjee DJ, Jacobsen LV, Hale PM, Arslanian S; NN2211-1800 Study Group. Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Diabetes Technol Ther. 2014 Oct;16(10):679-87. doi: 10.1089/dia.2013.0366. Epub 2014 Jul 18.
Petri KC, Jacobsen LV, Klein DJ. Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis. Clin Pharmacokinet. 2015 Jun;54(6):663-70. doi: 10.1007/s40262-014-0229-z.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1111-9256
Identifier Type: OTHER
Identifier Source: secondary_id
2010-021057-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN2211-1800
Identifier Type: -
Identifier Source: org_study_id
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