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Trial record 2 of 9 for:    lixisenatide | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02803918
First received: June 14, 2016
Last updated: September 12, 2017
Last verified: September 2017
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Lixisenatide (AVE0010) Drug: Placebo Drug: Basal Insulin Drug: Metformin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with adverse events (AEs) [ Time Frame: Up to 10 weeks ]
  • Number of patients with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 10 weeks ]
  • Number of patients with anti-lixisenatide antibodies [ Time Frame: Up to 10 weeks ]

Secondary Outcome Measures:
  • Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration [ Time Frame: Day 14, Day 28 and Day 42 ]
  • Assessment of PK parameters: maximum concentration (Cmax) [ Time Frame: Day 42 ]
  • Assessment of PK parameters: time to reach Cmax (Tmax) [ Time Frame: Day 42 ]
  • Assessment of PK parameters: area under up to last concentration (AUClast) [ Time Frame: Day 42 ]
  • Assessment of PK parameters: area under curve (AUC) [ Time Frame: Day 42 ]
  • Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours [ Time Frame: Day 14, Day 28 and Day 42 ]

Estimated Enrollment: 24
Actual Study Start Date: May 17, 2017
Estimated Study Completion Date: July 27, 2018
Estimated Primary Completion Date: July 27, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Lixisenatide (AVE0010)

Pharmaceutical form: solution

Route of administration: subcutaneous

Drug: Basal Insulin

Pharmaceutical form: solution

Route of administration: subcutaneous

Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral

Placebo Comparator: 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.
Drug: Placebo

Pharmaceutical form: solution

Route of administration: subcutaneous

Drug: Basal Insulin

Pharmaceutical form: solution

Route of administration: subcutaneous

Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral


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.
  Eligibility

Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/m^2.
  • Male and female patients with documented T2DM insufficiently controlled with metformin ≥1000 mg/day (or maximum tolerated dose according to the Investigator's judgment) 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.
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02803918

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
United States, Louisiana
Investigational Site Number 840002 Recruiting
Baton Rouge, Louisiana, United States, 70808
Investigational Site Number 840006 Recruiting
New Orleans, Louisiana, United States, 70115-6969
United States, Pennsylvania
Investigational Site Number 840009 Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Investigational Site Number 840007 Recruiting
Lufkin, Texas, United States, 75904
Mexico
Investigational Site Number 484001 Recruiting
Monterrey, Mexico, 64460
Investigational Site Number 484002 Recruiting
Puebla, Mexico, 72190
South Africa
Investigational Site Number 710-001 Recruiting
Cape Town, South Africa, 7530
Spain
Investigational Site Number 724001 Recruiting
Vitoria, Spain, 01009
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02803918     History of Changes
Other Study ID Numbers: TDR14311
U1111-1176-6142 ( Other Identifier: UTN )
Study First Received: June 14, 2016
Last Updated: September 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017