Back to resultsSafety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin aspart SAR341402
Insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
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.
Sites / Locations
- Investigational Site Number 8400001
- Investigational Site Number 8400002
- Investigational Site Number 8400003
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SAR341402/NovoLog
NovoLog/SAR341402
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Unexplained hyperglycemia
Number of patients with unexplained hyperglycemia. Unexplained hyperglycemia is defined as plasma glucose equal or above 250 mg/dL (13.9 mmol/L) whether or not corrected by a bolus through the insulin pump with no apparent material defects, medical, dietary, insulin dosing or pump failure. This will include infusion set occlusion as defined in the primary endpoint.
Intervals for infusion set changes
Intervals for infusion set changes will be derived as number of days in the treatment period divided by the number of infusion set changes in the treatment period.
Number of patients with insulin pump alarms for "non-delivery"
Number of patients with insulin pump "non-delivery" alarms (independent of confirmation of occlusion by hyperglycemia and failure to correct hyperglycemia by insulin bolus via the insulin pump).
Patient observation of infusion set occlusion
Patient observation of infusion set occlusion (independent of confirmation of occlusion by hyperglycemia and failure to correct hyperglycemia by insulin bolus via the insulin pump).
Adverse events and serious adverse events
Number patients with adverse events and/or serious adverse events, including bruising at the infusion site and injection site, and hypersensitivity reactions.
Number of patients with hypoglycemic events
Number of patients with hypoglycemic events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03436498
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
October 6, 2018 (Actual)
Study Completion Date
October 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAR341402/NovoLog
Arm Type
Experimental
Arm Description
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.
Arm Title
NovoLog/SAR341402
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin aspart SAR341402
Intervention Description
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
Insulin aspart
Intervention Description
Pharmaceutical form: Solution
Route of administration: Subcutaneous
Primary Outcome Measure Information:
Title
Infusion set occlusions
Description
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.
Time Frame
At week 4 from baseline of each treatment
Secondary Outcome Measure Information:
Title
Unexplained hyperglycemia
Description
Number of patients with unexplained hyperglycemia. Unexplained hyperglycemia is defined as plasma glucose equal or above 250 mg/dL (13.9 mmol/L) whether or not corrected by a bolus through the insulin pump with no apparent material defects, medical, dietary, insulin dosing or pump failure. This will include infusion set occlusion as defined in the primary endpoint.
Time Frame
At week 4 from baseline of each treatment
Title
Intervals for infusion set changes
Description
Intervals for infusion set changes will be derived as number of days in the treatment period divided by the number of infusion set changes in the treatment period.
Time Frame
At week 4 from baseline of each treatment
Title
Number of patients with insulin pump alarms for "non-delivery"
Description
Number of patients with insulin pump "non-delivery" alarms (independent of confirmation of occlusion by hyperglycemia and failure to correct hyperglycemia by insulin bolus via the insulin pump).
Time Frame
At week 4 from baseline of each treatment
Title
Patient observation of infusion set occlusion
Description
Patient observation of infusion set occlusion (independent of confirmation of occlusion by hyperglycemia and failure to correct hyperglycemia by insulin bolus via the insulin pump).
Time Frame
Up to 10 weeks
Title
Adverse events and serious adverse events
Description
Number patients with adverse events and/or serious adverse events, including bruising at the infusion site and injection site, and hypersensitivity reactions.
Time Frame
Up to 10 weeks
Title
Number of patients with hypoglycemic events
Description
Number of patients with hypoglycemic events.
Time Frame
At week 4 from baseline of each treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 8400001
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Investigational Site Number 8400002
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Investigational Site Number 8400003
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Citations:
PubMed Identifier
31833801
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.
Results Reference
result
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Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
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