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Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603510
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date May 19, 2016
Study Start Date  ICMJE November 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Frequency of infusion set occlusions [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • Number of infusion set changes in each treatment period [ Time Frame: 4 weeks ]
  • Number of insulin pump alarms for infusion set occlusions [ Time Frame: 4 weeks ]
  • Number of adverse events [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion
Official Title  ICMJE A Randomized, 2X4 Week, Active-Controlled, Open-Label, 2-Treatment Arm, 2-Period Cross-Over Study Assessing the Safety of SAR342434 and Humalog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)
Brief Summary

Primary Objective:

  • Assess the safety of SAR342434 and Humalog when used in external pumps.

Secondary Objectives:

  • Intervals for infusion set changes.
  • Incidence of insulin pump alarms for infusion set occlusion.
  • Patient observation of infusion set occlusion.
  • Adverse events including bruising at the infusion site and injection site reactions.
Detailed Description The study duration for each patient will be approximately 10 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: SAR342434

    Pharmaceutical form:solution

    Route of administration: subcutaneous

  • Drug: insulin lispro

    Pharmaceutical form:solution

    Route of administration: subcutaneous

    Other Name: Humalog
Study Arms  ICMJE
  • Experimental: SAR342434/Humalog
    SAR342434 and Humalog will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
    Interventions:
    • Drug: SAR342434
    • Drug: insulin lispro
  • Experimental: Humalog/SAR342434
    Humalog and SAR342434 will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
    Interventions:
    • Drug: SAR342434
    • Drug: insulin lispro
Publications * Thrasher J, Surks H, Nowotny I, Pierre S, Rotthaeuser B, Wernicke-Panten K, Garg S. Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump. J Diabetes Sci Technol. 2018 May;12(3):680-686. doi: 10.1177/1932296817753644. Epub 2018 Jan 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2016)
27
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
24
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Male and female subjects above the age of 18.
  • Patients with type 1 diabetes mellitus for at least 1 year prior to the screening visit.
  • At least 1 year of insulin treatment with at least 6 months of continuous subcutaneous insulin infusion (CSII) treatment with an external insulin pump.
  • Signed written informed consent.

Exclusion criteria:

  • HbA1c ≥8.5% at screening.
  • Diabetes other than type 1 diabetes mellitus.
  • History of abscess 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.
  • Hospitalization for diabetic ketoacidosis (DKA) in the last 6 months before screening visit.
  • Hypoglycemic unawareness as judged by the Investigator in the last 6 months before the screening visit.
  • History of severe hypoglycemia requiring treatment by emergency room admission or hospitalization in the last 6 months before 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 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 SAR342434 in any other clinical trial.
  • Pregnancy and lactation: Women of child bearing potential (WOCPB) (premenopausal, not surgically sterile for at least 3 months prior to the time of screening) not using highly effective (ie, with low failure rate <1% per year) method(s) of birth control throughout the study and/or unwilling to be tested for pregnancy.
  • Any contraindication to the use of Humalog as defined in the national product labels; history of hypersensitivity to Humalog or to any of the excipients.
  • Patients 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02603510
Other Study ID Numbers  ICMJE PDY13502
U1111-1170-3739 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP