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Trial record 45 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: SAR342434 Drug: insulin lispro Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.
Drug: SAR342434

Pharmaceutical form:solution

Route of administration: subcutaneous


Drug: insulin lispro

Pharmaceutical form:solution

Route of administration: subcutaneous

Other Name: Humalog

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.
Drug: SAR342434

Pharmaceutical form:solution

Route of administration: subcutaneous


Drug: insulin lispro

Pharmaceutical form:solution

Route of administration: subcutaneous

Other Name: Humalog




Primary Outcome Measures :
  1. Frequency of infusion set occlusions [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Number of infusion set changes in each treatment period [ Time Frame: 4 weeks ]
  2. Number of insulin pump alarms for infusion set occlusions [ Time Frame: 4 weeks ]
  3. Number of adverse events [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


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): NCT02603510


Locations
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United States, Arkansas
Investigational Site Number 840002
Little Rock, Arkansas, United States, 72205
United States, Colorado
Investigational Site Number 840001
Denver, Colorado, United States, 80262
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02603510     History of Changes
Other Study ID Numbers: PDY13502
U1111-1170-3739 ( Other Identifier: UTN )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs