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

NCT ID: NCT02803918

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2020-01-27

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.

Detailed Description

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

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lixisenatide

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.

Group Type: EXPERIMENTAL

Lixisenatide (AVE0010)

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Basal Insulin

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Metformin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Basal Insulin

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Metformin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Interventions

Lixisenatide (AVE0010)

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Placebo

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Basal Insulin

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Metformin

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840002

Baton Rouge, Louisiana, United States

Investigational Site Number 840006

New Orleans, Louisiana, United States

Investigational Site Number 840009

Philadelphia, Pennsylvania, United States

Investigational Site Number 840007

Lufkin, Texas, United States

Investigational Site Number 480001

Phoenix, , Mauritius

Investigational Site Number 484001

Monterrey, , Mexico

Investigational Site Number 484002

Puebla City, , Mexico

Investigational Site Number 710001

Cape Town, , South Africa

Investigational Site Number 724002

Barcelona, , Spain

Investigational Site Number 792002

Ankara, , Turkey (Türkiye)

Investigational Site Number 792001

Izmir, , Turkey (Türkiye)

Countries

United States; Mauritius; Mexico; South Africa; Spain; Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 35411611 (View on PubMed)

Other Identifiers

U1111-1176-6142

Identifier Type: OTHER

Identifier Source: secondary_id

TDR14311

Identifier Type: -

Identifier Source: org_study_id