A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

May 17, 2017

Primary Completion Date

January 27, 2020

Study Completion Date

January 27, 2020

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Lixisenatide (AVE0010)

"Pharmaceutical form: solution~Route of administration: subcutaneous"

DRUG

Placebo

"Pharmaceutical form: solution~Route of administration: subcutaneous"

DRUG

Basal Insulin

"Pharmaceutical form: solution~Route of administration: subcutaneous"

DRUG

Metformin

"Pharmaceutical form: tablet~Route of administration: oral"

Trial Locations (11)

7530

Investigational Site Number 710001, Cape Town

19104

Investigational Site Number 840009, Philadelphia

35100

Investigational Site Number 792001, Izmir

64460

Investigational Site Number 484001, Monterrey

72190

Investigational Site Number 484002, Puebla City

75904

Investigational Site Number 840007, Lufkin

70808-4124

Investigational Site Number 840002, Baton Rouge

70115-6969

Investigational Site Number 840006, New Orleans

Unknown

Investigational Site Number 480001, Phoenix

08009

Investigational Site Number 724002, Barcelona

06500

Investigational Site Number 792002, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT02803918 - A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM) | Biotech Hunter | Biotech Hunter