Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

Part of paid clinical trials in Cypress, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT00943501
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
  • placebo — DRUG
    Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)
  • liraglutide — DRUG
    Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).
  • placebo — DRUG
    Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg).

Study Details

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).

Key Dates

Start date
Nov 30, 2009
Status verified
Jan 2017
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: I.a
  • Placebo Comparator: I.b
  • Experimental: II.a
  • Placebo Comparator: II.b

Primary Outcome Measure

Number and type of adverse events [ Time Frame: up to 8 weeks ]

Locations (14)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteCypressCalifornia90630-
Novo Nordisk Investigational SiteLos AngelesCalifornia90036-
Novo Nordisk Investigational SiteLos AngelesCalifornia90048-1869-
Novo Nordisk Investigational SiteAuroraColorado80045-
Novo Nordisk Investigational SiteIowa CityIowa52242-
Novo Nordisk Investigational SiteLouisvilleKentucky40202-
Novo Nordisk Investigational SiteKansas CityMissouri64108-4619-
Novo Nordisk Investigational SiteCincinnatiOhio45229-
Novo Nordisk Investigational SiteClevelandOhio44106-
Novo Nordisk Investigational SiteToledoOhio43606-
Novo Nordisk Investigational SitePhiladelphiaPennsylvania19104-
Novo Nordisk Investigational SitePittsburghPennsylvania15224-
Novo Nordisk Investigational SiteMemphisTennessee38103-2800-
Novo Nordisk Investigational SiteDallasTexas75235-

Find similar trials in Cypress, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Cypress, CANovo Nordisk Investigational Site· Los Angeles, CANovo Nordisk Investigational Site· Aurora, CONovo Nordisk Investigational Site· Iowa City, IANovo Nordisk Investigational Site· Louisville, KYNovo Nordisk Investigational Site· Kansas City, MO

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