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

ID: NCT03436498
Status: Not yet recruiting
Phase: Phase 1
Start Date: April 04, 2018
First Submitted: February 12, 2018
Last Updated: February 12, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: N/A
Conditions: Type 1 Diabetes Mellitus
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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 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.
Condition or disease Intervention/treatment Phase

Type 1 Diabetes Mellitus

Drug: Insulin aspart SAR341402
Other Names
Drug: Insulin aspart
Other Names
Phase 1

Tracking Information

First Submitted DateFebruary 12, 2018
Last Update Posted DateFebruary 12, 2018
Anticipated Start DateApril 04, 2018
Anticipated Completion DateAugust 01, 2018
Anticipated Primary Completion DateAugust 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Infusion set occlusions [Time Frame: At week 4 from baseline of each treatment]

    Number of patients with infusion set occlusions. Infusion set occlusions are defined as infusion set change due to failure to correct hyperglycemia (plasma glucose ≥ 300 mg/dL [16.7 mmol/L]) by insulin bolus via the insulin pump.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Unexplained hyperglycemia [Time Frame: At week 4 from baseline of each treatment]

    Number of patients with unexplained hyperglycemia. Unexplained hyperglycemia is defined as plasma glucose equal or above 300 mg/dL (16.7 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 [Time Frame: 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.

  • Number of patients with insulin pump alarms for "non-delivery" [Time Frame: 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).

  • Patient observation of infusion set occlusion [Time Frame: 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).

  • Adverse events and serious adverse events [Time Frame: 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.

  • Number of patients with hypoglycemic events [Time Frame: At week 4 from baseline of each treatment]

    Number of patients with hypoglycemic events.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSafety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
Official TitleSafety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)
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 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.

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
30
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Type 1 Diabetes Mellitus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Insulin aspart SAR341402

Pharmaceutical form: Solution Route of administration: Subcutaneous

Other Names
Drug: Insulin aspart

Pharmaceutical form: Solution Route of administration: Subcutaneous

Other Names
Study Groups/Cohorts
SAR341402/NovoLog
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
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.

Study Arms
Experimental NovoLog/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

Experimental SAR341402/NovoLog
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
Pharmaceutical form: Solution Route of administration: Subcutaneous

Arm Intervention/Treatment
Experimental NovoLog/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
Experimental SAR341402/NovoLog
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

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment30
Completion DateAugust 01, 2018
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 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 3 months before screening visit.
- History of severe hypoglycemia requiring emergency room admission or hospitalization in the last 3 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 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03436498
Other Study ID Numbers
PDY15083
U1111-1200-1241
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi