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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02803918

TDR14311

U1111-1176-6142 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 23 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups, including a placebo group

Lixisenatide

Experimental group

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.

Treatment:

Drug: Metformin

Drug: Lixisenatide (AVE0010)

Drug: Basal Insulin

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo

Drug: Metformin

Drug: Basal Insulin