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

NCT03436498 | Completed Phase 1 FDA Drug

• 2 other identifiers: PDY15083U1111-1200-1241
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief 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.
• 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 \[according to ADA (American Diabetes Association) Workgroup on hypoglycemia\].

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (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.

  At week 4 from baseline of each treatment

Secondary Outcomes (6)

• Unexplained hyperglycemia

  At week 4 from baseline of each treatment

• Intervals for infusion set changes

  At week 4 from baseline of each treatment

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

  At week 4 from baseline of each treatment

• Patient observation of infusion set occlusion

  Up to 10 weeks

• Adverse events and serious adverse events

  Up to 10 weeks

Study Arms (2)

SAR341402/NovoLog

EXPERIMENTAL

SAR341402 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.

Drug: Insulin aspart SAR341402

NovoLog/SAR341402

EXPERIMENTAL

Novolog 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.

Drug: Insulin aspart

Interventions

Insulin aspart SAR341402 DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

SAR341402/NovoLog

Insulin aspart DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

NovoLog/SAR341402

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number 8400001

Little Rock, Arkansas, 72211, United States

Location

Investigational Site Number 8400002

Denver, Colorado, 80262, United States

Location

Investigational Site Number 8400003

West Des Moines, Iowa, 50265, United States

Location

Related Publications (1)

• 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.

  PMID: 31833801 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

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: February 12, 2018
• First Posted: February 19, 2018
• Study Start: May 10, 2018
• Primary Completion: October 6, 2018
• Study Completion: October 6, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)