Type 2 Diabetes MellitusPhase 1NCT02803918
A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing Lixisenatide (AVE0010), Basal Insulin and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 11 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Lixisenatide (AVE0010), Basal Insulin and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 17 May 2017to 27 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United States4 sites
Investigational Site Number 840002
Baton Rouge, Louisiana, 70808-4124
Investigational Site Number 840007
Lufkin, Texas, 75904
Investigational Site Number 840006
New Orleans, Louisiana, 70115-6969
Investigational Site Number 840009
Philadelphia, Pennsylvania, 19104
Mexico2 sites
Investigational Site Number 484001
Monterrey, 64460
Investigational Site Number 484002
Puebla City, 72190
Turkey (Türkiye)2 sites
Investigational Site Number 792002
Ankara, 06500
Investigational Site Number 792001
Izmir, 35100
About this study
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
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.
Read the 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
- Being tested
- Lixisenatide (AVE0010), Placebo, Basal Insulin, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lixisenatide (AVE0010)Drug
Pharmaceutical form: solution
Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: solution
Route of administration: subcutaneous
Basal InsulinDrug
Pharmaceutical form: solution
Route of administration: subcutaneous
MetforminDrug
Pharmaceutical form: tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Lixisenatide | Experimental | 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. Receives: Drug: Lixisenatide (AVE0010); Drug: Basal Insulin; Drug: Metformin |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Basal Insulin; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events (AEs)
Measured: Up to 10 weeks
Number of patients with treatment-emergent adverse events (TEAEs)
Measured: Up to 10 weeks
Number of patients with anti-lixisenatide antibodies
Measured: Up to 10 weeks
Secondary outcomes (6)
Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration
Measured: Day 14, Day 28 and Day 42
Assessment of PK parameters: maximum concentration (Cmax)
Measured: Day 42
Assessment of PK parameters: time to reach Cmax (Tmax)
Measured: Day 42
Assessment of PK parameters: area under up to last concentration (AUClast)
Measured: Day 42
Assessment of PK parameters: area under curve (AUC)
Measured: Day 42
Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours
Measured: Day 14, Day 28 and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start17 May 2017
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803918
- Sponsor's protocol ID
- TDR14311
- Other IDs
- U1111-1176-6142
- Status last verified
- Apr 2022
- First submitted
- 14 Jun 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 35411611
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02803918
- Acronym / sponsor ID
- TDR14311
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lixisenatide | Experimental | Drug: Lixisenatide (AVE0010), Drug: Basal Insulin, Drug: MetforminAdministration 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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Basal Insulin, Drug: MetforminAdministration 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lixisenatide (AVE0010)Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Lixisenatide |
| PlaceboPharmaceutical form: solution Route of administration: subcutaneous | Drug | Placebo |
| Basal InsulinPharmaceutical form: solution Route of administration: subcutaneous | Drug | Lixisenatide, Placebo |
| MetforminPharmaceutical form: tablet Route of administration: oral | Drug | Lixisenatide, Placebo |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 35411611Barrientos-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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lixisenatide (AVE0010), Basal Insulin and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Mexico, Turkey (Türkiye), Mauritius, South Africa and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (AEs) (time frame: Up to 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.