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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2022
• Main ID: NCT02803918
• Date of registration: 14/06/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)
• Scientific 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
• Date of first enrolment: May 17, 2017
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02803918
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
• Phase: Phase 1

Countries of recruitment

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

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Placebo

Drug: Metformin

Drug: Lixisenatide (AVE0010)

Drug: Basal Insulin

Primary Outcome(s)

Number of patients with anti-lixisenatide antibodies [Time Frame: Up to 10 weeks]

Number of patients with adverse events (AEs) [Time Frame: Up to 10 weeks]

Number of patients with treatment-emergent adverse events (TEAEs) [Time Frame: Up to 10 weeks]

Secondary Outcome(s)

Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration [Time Frame: Day 14, Day 28 and Day 42]

Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours [Time Frame: Day 14, Day 28 and Day 42]

Assessment of PK parameters: area under curve (AUC) [Time Frame: Day 42]

Assessment of PK parameters: area under up to last concentration (AUClast) [Time Frame: Day 42]

Assessment of PK parameters: time to reach Cmax (Tmax) [Time Frame: Day 42]

Assessment of PK parameters: maximum concentration (Cmax) [Time Frame: Day 42]

Secondary ID(s)

TDR14311

U1111-1176-6142

Source(s) of Monetary Support

Please refer to primary and secondary sponsors