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

NCT02603510 | Completed Phase 1

• 2 other identifiers: PDY13502U1111-1170-3739
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Frequency of infusion set occlusions

  4 weeks

Secondary Outcomes (3)

• Number of infusion set changes in each treatment period

  4 weeks

• Number of insulin pump alarms for infusion set occlusions

  4 weeks

• Number of adverse events

  4 weeks

Study Arms (2)

SAR342434/Humalog

EXPERIMENTAL

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; Drug: insulin lispro

Humalog/SAR342434

EXPERIMENTAL

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; Drug: insulin lispro

Interventions

SAR342434 DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Humalog/SAR342434; SAR342434/Humalog

insulin lispro DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Also known as: Humalog

Humalog/SAR342434; SAR342434/Humalog

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Investigational Site Number 840002

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840001

Denver, Colorado, 80262, United States

Location

Related Publications (1)

• 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.

  PMID: 29359575 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

SAR342434; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

US (2)