Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients

April 21, 2022 updated by: Sanofi

Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)

Primary Objective:

- To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms of the number of patients with infusion set occlusions.

Secondary Objectives:

  • To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of unexplained hyperglycemia.
  • To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of:
  • Intervals for infusion set changes.
  • Number of patients with insulin pump for "non-delivery" alarm.
  • Patient observation of infusion set occlusion.
  • Adverse events and serious adverse events.
  • Number of patients with hypoglycemic events [according to ADA (American Diabetes Association) Workgroup on hypoglycemia].

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study duration for each patient will be approximately 10 weeks, including a 2-week screening period, 2 treatment periods of 4 weeks each, and 1-day post-treatment safety follow-up period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Investigational Site Number 8400001
    • Colorado
      • Denver, Colorado, United States, 80262
        • Investigational Site Number 8400002
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Investigational Site Number 8400003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Male and female patients with Type 1 diabetes mellitus (T1DM).
  • Age greater than or equal to 18 at the screening visit.
  • Diabetes diagnosed at least 12 months before screening visit.
  • At least 1 year of insulin treatment with at least 6 months of CSII (Continuous Subcutaneous Insulin Infusion) treatment with an external insulin pump.
  • Demonstration of successful use of insulin pump and performing of a minimum of 4 blood glucose checks per day during screening.
  • Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for T1DM patients.
  • Signed written informed consent.

Exclusion criteria:

  • Hemoglobin A1c (HbA1c) ≥8.5% at screening.
  • Diabetes other than T1DM.
  • History of infection at the infusion site within 3 months prior to the screening visit (Visit 1).
  • Use of oral glucose-lowering agents or any injectable glucose-lowering agents other than insulin during the 3 months before screening visit.
  • Hospitalization for recurrent diabetic ketoacidosis (DKA) in the last 6 months before screening visit.
  • History of severe hypoglycemia requiring emergency room admission or hospitalization in the last 6 months before screening visit.
  • Hypoglycemic unawareness as judged by the Investigator in the last 6 months before the screening visit.
  • Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening that in the judgment of the investigator or any sub investigator would preclude safe completion of the study.
  • Known history of illegal drug or alcohol abuse within 6 months prior to the time of screening.
  • Use of investigational drug(s) within 3 months or 5 half-lives, whichever is longer, prior to the screening visit.
  • Patients who had previously received SAR341402 in any other clinical trial.
  • Any contraindication to the use of NovoLog® as defined in the national product labels; history of hypersensitivity to NovoLog® or to any of the excipients.
  • Pregnancy and lactation.
  • If female, pregnancy [defined as positive β-HCG (Human Chorionic Gonadotropin) in blood or in urine], breast-feeding.
  • Patient is an employee or relative of an employee of the sponsor.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: SAR341402/NovoLog
SAR341402 will be self-administered via continuous subcutaneous insulin infusion via an insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion. After 4 weeks of SAR341402 as treatment, patient will switch with NovoLog® as treatment.
Drug: Insulin aspart SAR341402

Pharmaceutical form: Solution

Route of administration: Subcutaneous
EXPERIMENTAL: NovoLog/SAR341402
Novolog will be self-administered via continuous subcutaneous insulin infusion via an insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion. After 4 weeks of NovoLog® as treatment, patient will switch with SAR341402 as treatment.
Drug: Insulin aspart

Pharmaceutical form: Solution

Route of administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Infusion set occlusions
Time Frame: At week 4 from baseline of each treatment
Number of patients with infusion set occlusions. Infusions set occlusions are defined as infusion set change due to failure to correct hyperglycemia (plasma glucose ≥ 250 mg/dL [13.9 mmol/L]) by insulin bolus via the insulin pump.
At week 4 from baseline of each treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Unexplained hyperglycemia
Time Frame: At week 4 from baseline of each treatment
Number of patients with unexplained hyperglycemia. Unexplained hyperglycemia is defined as plasma glucose equal or above 250 mg/dL (13.9 mmol/L) whether or not corrected by a bolus through the insulin pump with no apparent material defects, medical, dietary, insulin dosing or pump failure. This will include infusion set occlusion as defined in the primary endpoint.
At week 4 from baseline of each treatment
Intervals for infusion set changes
Time Frame: At week 4 from baseline of each treatment
Intervals for infusion set changes will be derived as number of days in the treatment period divided by the number of infusion set changes in the treatment period.
At week 4 from baseline of each treatment
Number of patients with insulin pump alarms for "non-delivery"
Time Frame: At week 4 from baseline of each treatment
Number of patients with insulin pump "non-delivery" alarms (independent of confirmation of occlusion by hyperglycemia and failure to correct hyperglycemia by insulin bolus via the insulin pump).
At week 4 from baseline of each treatment
Patient observation of infusion set occlusion
Time Frame: Up to 10 weeks
Patient observation of infusion set occlusion (independent of confirmation of occlusion by hyperglycemia and failure to correct hyperglycemia by insulin bolus via the insulin pump).
Up to 10 weeks
Adverse events and serious adverse events
Time Frame: Up to 10 weeks
Number patients with adverse events and/or serious adverse events, including bruising at the infusion site and injection site, and hypersensitivity reactions.
Up to 10 weeks
Number of patients with hypoglycemic events
Time Frame: At week 4 from baseline of each treatment
Number of patients with hypoglycemic events.
At week 4 from baseline of each treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDY15083
  • U1111-1200-1241 (OTHER: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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