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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02803918
Other study ID # TDR14311
Secondary ID U1111-1176-6142
Status Completed
Phase Phase 1
First received
Last updated
Start date May 17, 2017
Est. completion date January 27, 2020

Study information

Verified date April 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with T2DM. Secondary Objectives: - To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric patients with T2DM. - To evaluate the change from baseline in fasting and post-prandial plasma glucose concentrations during a standardized meal test after 3 ascending repeated doses of lixisenatide in comparison to placebo.


Description:

The total study duration will be up to 10 weeks that includes a 6-week treatment period with dose escalation every 2 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 27, 2020
Est. primary completion date January 27, 2020
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion criteria : - Male or female patients aged =10 and <18 years old (at least 4 patients below 16 years old). - Body mass index (BMI) >85th percentile for age and gender; BMI =50 kg/m2. - Male and female patients with documented T2DM insufficiently controlled with metformin at a stable dose and regimen for 8 weeks prior to randomization and/or basal insulin at stable dose (± 20%) and regimen for 8 weeks prior to randomization. The exact individual metformin dose will be selected according to local regulation and to the investigator's medical judgment. - Glycated hemoglobin (HbA1c) >6.5% and =11% at screening. Exclusion criteria: - If female, ongoing pregnancy (defined as positive serum pregnancy test), breast-feeding. - Sexually active postmenarchal female patient who does not agree to use an adequate and highly effective method of contraception throughout the study duration and according to local regulation (ie, hormonal contraception, condom, etc.). - Diabetes other than T2DM. - Fasting plasma glucose >250 mg/dL (>13.9 mmol/L) at screening. - Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin and basal insulin (eg, alpha glucosidase inhibitor, glucagon-like peptide (GLP-1) receptor agonist, dipeptidyl peptidase-IV (DPP-IV) inhibitors, short-acting insulin etc.) within 1 month prior to the screening visit. - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design


Intervention

Drug:
Lixisenatide (AVE0010)
Pharmaceutical form: solution Route of administration: subcutaneous
Placebo
Pharmaceutical form: solution Route of administration: subcutaneous
Basal Insulin
Pharmaceutical form: solution Route of administration: subcutaneous
Metformin
Pharmaceutical form: tablet Route of administration: oral

Locations

Country Name City State
Mauritius Investigational Site Number 480001 Phoenix
Mexico Investigational Site Number 484001 Monterrey
Mexico Investigational Site Number 484002 Puebla
South Africa Investigational Site Number 710001 Cape Town
Spain Investigational Site Number 724002 Barcelona
Turkey Investigational Site Number 792002 Ankara
Turkey Investigational Site Number 792001 Izmir
United States Investigational Site Number 840002 Baton Rouge Louisiana
United States Investigational Site Number 840007 Lufkin Texas
United States Investigational Site Number 840006 New Orleans Louisiana
United States Investigational Site Number 840009 Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Mauritius,  Mexico,  South Africa,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with adverse events (AEs) Up to 10 weeks
Primary Number of patients with treatment-emergent adverse events (TEAEs) Up to 10 weeks
Primary Number of patients with anti-lixisenatide antibodies Up to 10 weeks
Secondary Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration Day 14, Day 28 and Day 42
Secondary Assessment of PK parameters: maximum concentration (Cmax) Day 42
Secondary Assessment of PK parameters: time to reach Cmax (Tmax) Day 42
Secondary Assessment of PK parameters: area under up to last concentration (AUClast) Day 42
Secondary Assessment of PK parameters: area under curve (AUC) Day 42
Secondary Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours Day 14, Day 28 and Day 42
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