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A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03202875
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.

Secondary Objective:

To assess the safety and tolerability of SAR341402.


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

Detailed Description:
The total study duration for a screened subject will be about 3 - 8 weeks (excluding screening of 2 to 28 days), treatment period of 2 days for each 3 periods (1 overnight stay), a washout period of 5-18 days (preferentially 7 days between consecutive dosing), and an end-of-study visit of 1 day between Days 5 and 14 after the last administration of the investigational product.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR341402 to NovoRapid® and NovoLog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus
Actual Study Start Date : November 14, 2012
Actual Primary Completion Date : December 28, 2012
Actual Study Completion Date : December 28, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Test (T)
SAR341402: single dose injection
Drug: SAR341402

Pharmaceutical form: solution

Route of administration: subcutaneous


Active Comparator: Reference 1 (R1)
NovoRapid®: single dose injection
Drug: Insulin Aspart

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: NovoRapid®

Active Comparator: Reference 2 (R2)
NovoLog®: single dose injection
Drug: Insulin Aspart

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: NovoLog®




Primary Outcome Measures :
  1. Assessment of PK parameters: maximum plasma concentration (Cmax) [ Time Frame: 12 hours ]
    Maximum plasma concentration (Cmax) of SAR341402, NovoRapid and NovoLog within 12 hours

  2. Assessment of PK parameters: Area under the concentration versus time curve (AUC) [ Time Frame: 12 hours ]
    INS-AUC of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours

  3. Assessment of PK parameter: AUC from dosing to last concentration (AUClast) [ Time Frame: 12 hours ]
    INS-AUClast is AUC from the time of dosing to the last measurable concentration of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours

  4. Assessment of PD parameters: Area under the body weight standardized glucose infusion rate (GIR) [ Time Frame: 12 hours ]
    Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)


Secondary Outcome Measures :
  1. Assessment of PK: Fractional area under the concentration versus time curve [ Time Frame: 12 hours ]
    INS-AUC0-2 and INS-AUC4-tlast

  2. Assessment of PK: Time to 20 % of INS-AUC [ Time Frame: 12 hours ]
    Time to 20% of AUC (t20%-INS-AUC) within 12 hours

  3. Assessment of PK: time to reach INS-Cmax (INS-tmax) [ Time Frame: 12 hours ]
    INS-tmax within 12 hours

  4. Assessment of PK: time to reach INS-t1/2z (INS-t1/2z) [ Time Frame: 12 hours ]
    INS-t1/2z within 12 hours

  5. Assessment of PD: Fractional area under the body weight standardized GIR versus time curve [ Time Frame: 12 hours ]
    GIR-AUC0-2 and GIR-AUC4-12

  6. Assessment of PD: Time to 20 % of total GIR-AUC0-12h [ Time Frame: 12 hours ]
    Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h) within 12 hours

  7. Assessment of PD: Maximum smoothed body weight standardized GIR (GIRmax) [ Time Frame: 12 hours ]
    Maximum smoothed body weight standardized GIR (GIRmax) within 12 hours

  8. Assessment of PD: Time to GIRmax (GIR-tmax) [ Time Frame: 12 hours ]
    Time to GIRmax (GIR-tmax) within 12 hours

  9. Number of adverse events (AEs) [ Time Frame: 8 weeks ]
    Number of patients with treatment emergent AEs and serious adverse events (SAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Male or female subjects with diabetes mellitus type 1 for more than one year.
  • Total insulin dose of < 1.2 U/kg/day.
  • Fasting negative serum C-peptide (< 0.3 nmol/L).
  • Glycohemoglobin (HbA1c) ≤ 9%.
  • Stable insulin regimen for at least 2 months prior to study.
  • Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.

Exclusion criteria:

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
  • More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month.
  • Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
  • Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, thyroid hormones, lipid-lowering and antihypertensive drugs and if female with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days.
  • Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab.

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): NCT03202875


Locations
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Germany
Investigational Site 276001
Neuss, Germany
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03202875     History of Changes
Other Study ID Numbers: PDY12695
2012-002355-42 ( EudraCT Number )
U1111-1127-2950 ( Other Identifier: UTN )
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs