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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: SAR342434; Drug: insulin lispro

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Investigational Site Number 840002
  • Colorado
    • Denver, Colorado, United States, 80262
      • Investigational Site Number 840001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: SAR342434; Pharmaceutical form:solution Route of administration: subcutaneous; Drug: insulin lispro; Pharmaceutical form:solution Route of administration: subcutaneous; Other Names: Humalog
Experimental: 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.	Drug: SAR342434; Pharmaceutical form:solution Route of administration: subcutaneous; Drug: insulin lispro; Pharmaceutical form:solution Route of administration: subcutaneous; Other Names: Humalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of infusion set occlusions	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	4 weeks
Number of infusion set changes in each treatment period	4 weeks
Number of insulin pump alarms for infusion set occlusions	4 weeks

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Estimate): May 19, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: PDY13502; U1111-1170-3739 (Other Identifier: UTN)