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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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ClinicalTrials.gov Identifier: NCT03436498
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
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].

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin aspart SAR341402 Drug: Insulin aspart Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : October 4, 2018
Estimated Study Completion Date : October 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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


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





Primary Outcome Measures :
  1. Infusion set occlusions [ Time Frame: 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 :
  1. 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 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436498


Contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com

Locations
United States, Arkansas
Investigational Site Number 8400001 Recruiting
Little Rock, Arkansas, United States, 72211
United States, Colorado
Investigational Site Number 8400002 Recruiting
Denver, Colorado, United States, 80262
United States, Iowa
Investigational Site Number 8400003 Recruiting
West Des Moines, Iowa, United States, 50265
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03436498     History of Changes
Other Study ID Numbers: PDY15083
U1111-1200-1241 ( Other Identifier: UTN )
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemic Agents
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Physiological Effects of Drugs