AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 1NCT02603510

Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion

A Phase 1 study testing SAR342434 and insulin lispro in people with Type 1 Diabetes Mellitus, run by Sanofi at 2 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: Assess the safety of SAR342434 and Humalog when used in external pumps. Secondary Objectives: Intervals for infusion set changes. Incidence of insulin pump alarms for infusion set occlusion. Patient observation of infusion set occlusion. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
SAR342434 and insulin lispro
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
2 sitesUnited States
Study dates
Nov 2015to Apr 2016
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects above the age of 18.
  • Patients with type 1 diabetes mellitus for at least 1 year prior to the screening visit.
  • At least 1 year of insulin treatment with at least 6 months of continuous subcutaneous insulin infusion (CSII) treatment with an external insulin pump.
  • Signed written informed consent.

Who cannot join

  • HbA1c ≥8.5% at screening.
  • Diabetes other than type 1 diabetes mellitus.
  • History of abscess 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.
  • Hospitalization for diabetic ketoacidosis (DKA) in the last 6 months before screening visit.
  • Hypoglycemic unawareness as judged by the Investigator in the last 6 months before the screening visit.
Show all 15Show fewer
  • History of severe hypoglycemia requiring treatment by emergency room admission or hospitalization in the last 6 months before 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 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 SAR342434 in any other clinical trial.
  • Pregnancy and lactation: Women of child bearing potential (WOCPB) (premenopausal, not surgically sterile for at least 3 months prior to the time of screening) not using highly effective (ie, with low failure rate <1% per year) method(s) of birth control throughout the study and/or unwilling to be tested for pregnancy.
  • Any contraindication to the use of Humalog as defined in the national product labels; history of hypersensitivity to Humalog or to any of the excipients.
  • Patients 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

2 sites in 1 country.

United States2 sites

  • Investigational Site Number 840001

    Denver, Colorado, 80262

  • Investigational Site Number 840002

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: A Randomized, 2X4 Week, Active-Controlled, Open-Label, 2-Treatment Arm, 2-Period Cross-Over Study Assessing the Safety of SAR342434 and Humalog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)

Primary Objective:

  • Assess the safety of SAR342434 and Humalog when used in external pumps.

Secondary Objectives:

  • Intervals for infusion set changes.
  • Incidence of insulin pump alarms for infusion set occlusion.
  • Patient observation of infusion set occlusion.
  • Adverse events including bruising at the infusion site and injection site reactions.
Read the detailed description

The study duration for each patient will be approximately 10 weeks.

Being tested
SAR342434, insulin lispro
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.

  • SAR342434Drug

    Pharmaceutical form:solution

    Route of administration: subcutaneous

  • insulin lisproDrug

    Also called Humalog

    Pharmaceutical form:solution

    Route of administration: subcutaneous

Study groups in NCT02603510
Study groupRoleWhat they receive
SAR342434/HumalogExperimentalSAR342434 and Humalog will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
Receives: Drug: SAR342434; Drug: insulin lispro
Humalog/SAR342434ExperimentalHumalog and SAR342434 will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
Receives: Drug: SAR342434; Drug: insulin lispro

What is being measured

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

  1. Frequency of infusion set occlusions

    Measured: 4 weeks

Secondary outcomes (3)

  1. Number of infusion set changes in each treatment period

    Measured: 4 weeks

  2. Number of insulin pump alarms for infusion set occlusions

    Measured: 4 weeks

  3. Number of adverse events

    Measured: 4 weeks

Timeline

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

  1. First posted11 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionApr 2016
  4. Study completionApr 2016

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603510
Sponsor's protocol ID
PDY13502
Other IDs
U1111-1170-3739
Status last verified
May 2016
First submitted
10 Nov 2015
Last updated
19 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Thrasher J, Surks H, Nowotny I, Pierre S, Rotthaeuser B, Wernicke-Panten K, Garg S. Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump. J Diabetes Sci Technol. 2018 May;12(3):680-686. doi: 10.1177/1932296817753644. Epub 2018 Jan 23.

    PubMed 29359575

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR342434 and insulin lispro in people with Type 1 Diabetes Mellitus, run by Sanofi at 2 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 4 inclusion and 15 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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Frequency of infusion set occlusions (time frame: 4 weeks). 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 NCT02603510, 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 19 May 2016.

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