Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03436498
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SAR341402/NovoLog Insulin aspart SAR341402 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/SAR341402 Insulin aspart 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.
- Primary Outcome Measures
Name Time Method Infusion set occlusions At week 4 from baseline of each treatment 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
Name Time Method Intervals for infusion set changes At week 4 from baseline of each treatment 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.
Patient observation of infusion set occlusion Up to 10 weeks 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).
Unexplained hyperglycemia At week 4 from baseline of each treatment 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.
Number of patients with hypoglycemic events At week 4 from baseline of each treatment Number of patients with hypoglycemic events.
Number of patients with insulin pump alarms for "non-delivery" At week 4 from baseline of each treatment 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).
Adverse events and serious adverse events Up to 10 weeks Number patients with adverse events and/or serious adverse events, including bruising at the infusion site and injection site, and hypersensitivity reactions.
Trial Locations
- Locations (3)
Investigational Site Number 8400001
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8400002
🇺🇸Denver, Colorado, United States
Investigational Site Number 8400003
🇺🇸West Des Moines, Iowa, United States