A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 9/29/2018 |
| Start Date: | May 17, 2017 |
| End Date: | January 27, 2020 |
| Contact: | Trial Transparency email recommended (Toll free number for US & Canada) |
| Email: | Contact-Us@sanofi.com |
| Phone: | 800-633-1610 |
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
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.
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.
The total study duration will be up to 10 weeks that includes a 6-week treatment period with
dose escalation every 2 weeks.
dose escalation every 2 weeks.
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.
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