← Trials/Trial dossier/NCT00943501

CompletedPhase 1

Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

20

Recruiting sites

Enrollment

21

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

HbA1c 6.5-11%Age 10-17

Primary endpoint

Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00943501
Org study IDNN2211-1800
Secondary ID2010-021057-39
Secondary IDU1111-1111-9256WHO

Timeline

Milestones

Study first posted2009-07-22estimated
Last update posted2017-01-26estimated
Study start2009-11 (month precision)
Primary completion2011-09actual (month precision)
Study completion2011-09actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

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)

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
2
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin

Time frame:throughout study duration (pre-, during and post-treatment)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number and type of adverse events

Time frame:up to 8 weeks

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Pharmacokinetics: Area under the plasma concentration vs. time curve

Time frame:within dosing interval

AUC₀–∞

concentration, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.