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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603510
• Other study ID #: PDY13502
• Secondary ID: U1111-1170-3739
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2015
• Last updated: May 18, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The study duration for each patient will be approximately 10 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• SAR342434
Pharmaceutical form:solution Route of administration: subcutaneous
• insulin lispro
Pharmaceutical form:solution Route of administration: subcutaneous

Locations

Country	Name	City	State
United States	Investigational Site Number 840001	Denver	Colorado
United States	Investigational Site Number 840002	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of infusion set occlusions		4 weeks	Yes
Secondary	Number of infusion set changes in each treatment period		4 weeks	Yes
Secondary	Number of insulin pump alarms for infusion set occlusions		4 weeks	Yes
Secondary	Number of adverse events		4 weeks	Yes