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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled, Dose Escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin and/or Basal Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803918
• Other study ID #: TDR14311
• Secondary ID: U1111-1176-6142
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

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