NCT00943501|CompletedPhase 1DMC

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN2211-1800U1111-1111-92562010-021057-39

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredJul 2009

StartedNov 2009

CompletionSep 2011

Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1 diabetes

Timeline

Completed

Started Nov 2009

Longer than P75 for phase_1 diabetes

Geographic Reach

4 countries

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

July 21, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed

3 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

July 21, 2009

Last Update Submit

January 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Number and type of adverse events
up to 8 weeks

Secondary Outcomes (2)

Pharmacokinetics: Area under the plasma concentration vs. time curve
within dosing interval
Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin
throughout study duration (pre-, during and post-treatment)

Study Arms (4)

I.a

EXPERIMENTAL

Drug: liraglutide

I.b

PLACEBO COMPARATOR

Drug: placebo

II.a

EXPERIMENTAL

Drug: liraglutide

II.b

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)

I.a

placeboDRUG

Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg)

I.b

Eligibility Criteria

Age10 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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%

You may not qualify if:

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)

Contact the study team to confirm eligibility.