A Phase 1 interventional study of Insulin aspart SAR341402 and Insulin aspart in Type 1 Diabetes Mellitus, sponsored by Sanofi. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 1, Interventional, and Treatment
Primary Objective:
Secondary Objectives:
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.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 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
Pharmaceutical form: Solution Route of administration: Subcutaneous
Pharmaceutical form: Solution Route of administration: Subcutaneous
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.
Time frame: At week 4 from baseline of each treatment
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.
Time frame: At week 4 from baseline of each treatment
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.
Time frame: At week 4 from baseline of each treatment
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).
Time frame: At week 4 from baseline of each treatment
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).
Time frame: Up to 10 weeks
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.
Time frame: Up to 10 weeks
Number of patients with hypoglycemic events
Number of patients with hypoglycemic events.
Time frame: At week 4 from baseline of each treatment
Plan to share: Yes — 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
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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