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

NCT02803918 | Completed Phase 1 FDA Drug

• 2 other identifiers: TDR14311U1111-1176-6142
• Study Type: interventional
• Target: 23
• Locations: 6 countries
• Sites: 11

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Number of patients with adverse events (AEs)

  Up to 10 weeks

• Number of patients with treatment-emergent adverse events (TEAEs)

  Up to 10 weeks

• Number of patients with anti-lixisenatide antibodies

  Up to 10 weeks

Secondary Outcomes (6)

• Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration

  Day 14, Day 28 and Day 42

• Assessment of PK parameters: maximum concentration (Cmax)

  Day 42

• Assessment of PK parameters: time to reach Cmax (Tmax)

  Day 42

• Assessment of PK parameters: area under up to last concentration (AUClast)

  Day 42

• Assessment of PK parameters: area under curve (AUC)

  Day 42

Study Arms (2)

Lixisenatide

EXPERIMENTAL

Administration of 3 ascending repeated doses of lixisenatide once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.

Drug: Lixisenatide (AVE0010); Drug: Basal Insulin; Drug: Metformin

Placebo

PLACEBO COMPARATOR

Administration of 3 ascending repeated doses of matching placebo once daily and subcutaneously. Background therapy (metformin and basal insulin) will be administered daily about the same time as usually done.

Drug: Placebo; Drug: Basal Insulin; Drug: Metformin

Interventions

Lixisenatide (AVE0010) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Lixisenatide

Placebo DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Placebo

Basal Insulin DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Lixisenatide; Placebo

Metformin DRUG

Pharmaceutical form: tablet Route of administration: oral

Lixisenatide; Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (11)

Investigational Site Number 840002

Baton Rouge, Louisiana, 70808-4124, United States

Location

Investigational Site Number 840006

New Orleans, Louisiana, 70115-6969, United States

Location

Investigational Site Number 840009

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number 840007

Lufkin, Texas, 75904, United States

Location

Investigational Site Number 480001

Phoenix, Mauritius

Location

Investigational Site Number 484001

Monterrey, 64460, Mexico

Location

Investigational Site Number 484002

Puebla City, 72190, Mexico

Location

Investigational Site Number 710001

Cape Town, 7530, South Africa

Location

Investigational Site Number 724002

Barcelona, 08009, Spain

Location

Investigational Site Number 792002

Ankara, 06500, Turkey (Türkiye)

Location

Investigational Site Number 792001

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• Barrientos-Perez M, Hsia DS, Sloan L, Nell H, Mungur O, Hovsepian L, Schmider W, Spranger R, Yang N, Niemoeller E. A study on pharmacokinetics, pharmacodynamics and safety of lixisenatide in children and adolescents with type 2 diabetes. Pediatr Diabetes. 2022 Sep;23(6):641-648. doi: 10.1111/pedi.13343. Epub 2022 Apr 24.

  PMID: 35411611 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: May 17, 2017
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

MA (1); ZA (1); ES (1); TU (2); ME (2); US (4)