AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 1NCT03436498

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

A Phase 1 study testing Insulin aspart SAR341402 and Insulin aspart in people with Type 1 Diabetes Mellitus, run by Sanofi at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Insulin aspart SAR341402 and Insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
3 sitesUnited States
Study dates
10 May 2018to 6 Oct 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Investigational Site Number 8400002

    Denver, Colorado, 80262

  • Investigational Site Number 8400001

    Little Rock, Arkansas, 72211

  • Investigational Site Number 8400003

    West Des Moines, Iowa, 50265

Other trials in United States

About this study

Official title: 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].
Read the 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.

Being tested
Insulin aspart SAR341402, Insulin aspart
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin aspart SAR341402Drug

    Pharmaceutical form: Solution

    Route of administration: Subcutaneous

  • Insulin aspartDrug

    Pharmaceutical form: Solution

    Route of administration: Subcutaneous

Study groups in NCT03436498
Study groupRoleWhat they receive
SAR341402/NovoLogExperimentalSAR341402 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.
Receives: Drug: Insulin aspart SAR341402
NovoLog/SAR341402ExperimentalNovolog 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.
Receives: Drug: Insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infusion set occlusions

    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.

    Measured: At week 4 from baseline of each treatment

Secondary outcomes (6)

  1. Unexplained hyperglycemia

    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.

    Measured: At week 4 from baseline of each treatment

  2. Intervals for infusion set changes

    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.

    Measured: At week 4 from baseline of each treatment

  3. Number of patients with insulin pump alarms for "non-delivery"

    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).

    Measured: At week 4 from baseline of each treatment

  4. Patient observation of infusion set occlusion

    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).

    Measured: Up to 10 weeks

  5. Adverse events and serious adverse events

    Number patients with adverse events and/or serious adverse events, including bruising at the infusion site and injection site, and hypersensitivity reactions.

    Measured: Up to 10 weeks

  6. Number of patients with hypoglycemic events

    Number of patients with hypoglycemic events.

    Measured: At week 4 from baseline of each treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start10 May 2018
  3. Primary completion6 Oct 2018
  4. Study completion6 Oct 2018

Resources

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
Crossover
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03436498
Sponsor's protocol ID
PDY15083
Other IDs
U1111-1200-1241
Status last verified
Apr 2022
First submitted
12 Feb 2018
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

  • Thrasher J, Polsky S, Hovsepian L, Nowotny I, Pierre S, Bois De Fer B, Bhargava A, Mukherjee B, Garg SK. Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial. Diabetes Technol Ther. 2020 Sep;22(9):666-673. doi: 10.1089/dia.2019.0446. Epub 2020 Jan 28.

    PubMed 31833801

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Insulin aspart SAR341402 and Insulin aspart in people with Type 1 Diabetes Mellitus, run by Sanofi at 3 sites in United States.

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 7 inclusion and 16 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 3 sites in United States. 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. 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?

Infusion set occlusions (time frame: At week 4 from baseline of each treatment). 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 NCT03436498, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in