Clinical trial NCT03436498: Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
Official title: Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: The study duration for each patient will be approximately 10 weeks, including a 2-week screening period, 2 treatment periods of 4 weeks each, and 1-day post-treatment safety follow-up period.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Infusion set occlusions
timeFrame: At week 4 from baseline of each treatment
Secondary outcomes:
measure: Unexplained hyperglycemia
timeFrame: At week 4 from baseline of each treatment
measure: Intervals for infusion set changes
timeFrame: At week 4 from baseline of each treatment
measure: Number of patients with insulin pump alarms for "non-delivery"
timeFrame: At week 4 from baseline of each treatment
measure: Patient observation of infusion set occlusion
timeFrame: Up to 10 weeks
measure: Adverse events and serious adverse events
timeFrame: Up to 10 weeks
measure: Number of patients with hypoglycemic events
timeFrame: At week 4 from baseline of each treatment
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Investigational Site Number 8400001
state: Arkansas
city: Denver
country: United States
facility: Investigational Site Number 8400002
state: Colorado
city: West Des Moines
country: United States
facility: Investigational Site Number 8400003
state: Iowa
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.