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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lixisenatide (AVE0010)
Placebo
Basal Insulin
Metformin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840002
  • Investigational Site Number 840006
  • Investigational Site Number 840009
  • Investigational Site Number 840007
  • Investigational Site Number 480001
  • Investigational Site Number 484001
  • Investigational Site Number 484002
  • Investigational Site Number 710001
  • Investigational Site Number 724002
  • Investigational Site Number 792002
  • Investigational Site Number 792001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lixisenatide

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of patients with adverse events (AEs)
Number of patients with treatment-emergent adverse events (TEAEs)
Number of patients with anti-lixisenatide antibodies

Secondary Outcome Measures

Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration
Assessment of PK parameters: maximum concentration (Cmax)
Assessment of PK parameters: time to reach Cmax (Tmax)
Assessment of PK parameters: area under up to last concentration (AUClast)
Assessment of PK parameters: area under curve (AUC)
Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours

Full Information

First Posted
June 14, 2016
Last Updated
April 22, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02803918
Brief Title
A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
January 27, 2020 (Actual)
Study Completion Date
January 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lixisenatide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lixisenatide (AVE0010)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Basal Insulin
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Number of patients with adverse events (AEs)
Time Frame
Up to 10 weeks
Title
Number of patients with treatment-emergent adverse events (TEAEs)
Time Frame
Up to 10 weeks
Title
Number of patients with anti-lixisenatide antibodies
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration
Time Frame
Day 14, Day 28 and Day 42
Title
Assessment of PK parameters: maximum concentration (Cmax)
Time Frame
Day 42
Title
Assessment of PK parameters: time to reach Cmax (Tmax)
Time Frame
Day 42
Title
Assessment of PK parameters: area under up to last concentration (AUClast)
Time Frame
Day 42
Title
Assessment of PK parameters: area under curve (AUC)
Time Frame
Day 42
Title
Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours
Time Frame
Day 14, Day 28 and Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840002
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4124
Country
United States
Facility Name
Investigational Site Number 840006
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115-6969
Country
United States
Facility Name
Investigational Site Number 840009
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Investigational Site Number 840007
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Investigational Site Number 480001
City
Phoenix
Country
Mauritius
Facility Name
Investigational Site Number 484001
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 484002
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Facility Name
Investigational Site Number 710001
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Investigational Site Number 724002
City
Barcelona
ZIP/Postal Code
08009
Country
Spain
Facility Name
Investigational Site Number 792002
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Investigational Site Number 792001
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Citations:
PubMed Identifier
35411611
Citation
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.
Results Reference
derived

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

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