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

NCT ID: NCT02603510

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-04-30

Brief 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.
• Adverse events including bruising at the infusion site and injection site reactions.

Detailed Description

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

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAR342434/Humalog

SAR342434 and Humalog will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.

Group Type: EXPERIMENTAL

SAR342434

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: subcutaneous

insulin lispro

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: subcutaneous

Humalog/SAR342434

Humalog and SAR342434 will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.

Group Type: EXPERIMENTAL

SAR342434

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: subcutaneous

insulin lispro

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: subcutaneous

Interventions

SAR342434

Pharmaceutical form:solution

Route of administration: subcutaneous

Intervention Type: DRUG

insulin lispro

Pharmaceutical form:solution

Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Humalog

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840002

Little Rock, Arkansas, United States

Investigational Site Number 840001

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29359575 (View on PubMed)

Other Identifiers

U1111-1170-3739

Identifier Type: OTHER

Identifier Source: secondary_id

PDY13502

Identifier Type: -

Identifier Source: org_study_id