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A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02273258
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.

Secondary Objective:

To assess the safety and tolerability of SAR342434.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: SAR342434 Drug: Insulin Lispro Phase 1

Detailed Description:

The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)

  • Screening: 2 to 28 days (D -28 to D -2)
  • Treatment period 1 - 3: 2 days (1 overnight stay)
  • Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)
  • End-of-study visit: 1 day between D 5 and D14 after last administration of 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 SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus
Study Start Date : March 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Test (T)
SAR342434: single dose injection
Drug: SAR342434
Pharmaceutical form:solution Route of administration: subcutaneous

Active Comparator: Reference 1 (R1)
US-approved Humalog®: single dose injection
Drug: Insulin Lispro
Pharmaceutical form:solution Route of administration: subcutaneous

Active Comparator: Reference 2 (R2)
EU-approved Humalog®: single dose injection
Drug: Insulin Lispro
Pharmaceutical form:solution Route of administration: subcutaneous




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog [ Time Frame: 12 hours ]
  2. Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog [ Time Frame: 12 hours ]
  3. Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12) [ Time Frame: 12 hours ]

Secondary Outcome Measures :
  1. The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X) [ Time Frame: 12 hours ]
  2. Time to 20% of AUC (t20%-AUC) [ Time Frame: 12 hours ]
  3. NS-tmax, INS-t1/2z [ Time Frame: 12 hours ]
  4. The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X) [ Time Frame: 12 hours ]
  5. Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h) [ Time Frame: 12 hours ]
  6. Maximum smoothed body weight standardized GIR (GIRmax) [ Time Frame: 12 hours ]
  7. Time to GIRmax (GIR-tmax) [ Time Frame: 12 hours ]
  8. Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels) [ Time Frame: 12 hours ]
  9. Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia [ Time Frame: 8 weeks ]


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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.
  • Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children).

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): NCT02273258


Locations
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Germany
Sanofi Administrative Office
Frankfurt, 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: NCT02273258     History of Changes
Other Study ID Numbers: PDY12704
2012-004453-86
U1111-1134-4816 ( Other Identifier: UTN )
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
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