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A Bioequivalence Study Comparing Two Different Strenghts Formulations of Insulin Lispro in Patients With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03903016
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose

Secondary Objectives:

  • To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose
  • To assess the safety and tolerability of the test and the reference formulation of insulin lispro

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

Detailed Description:
Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Single-dose, 2-treatment, 2-period, 2-sequence Crossover Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Test (T)
Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period
Drug: Insulin Lispro SAR342434
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Active Comparator: Reference (R)
Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period
Drug: Insulin Lispro SAR342434
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Insulin lispro Sanofi®




Primary Outcome Measures :
  1. Assessment of pharmacokinetc (PK) parameter:INS-Cmax [ Time Frame: 10 hours ]
    Maximum Insulin (INS) concentration

  2. Assessment of PK parameter :INS-AUClast - [ Time Frame: 10 hours ]
    Area under INS concentration time curve from 0 to last measurable concentration -


Secondary Outcome Measures :
  1. Assessment of PK parameter:INS-AUC [ Time Frame: 10 hours ]
    Area under INS concentration time curve from 0 to infinity

  2. Assessment of PK parameter:INS-tmax [ Time Frame: 10 hours ]
    Time to reach INS-Cmax

  3. Assessment of PK parameter:INS-t1/2z [ Time Frame: 10 hours ]
    INS terminal half life

  4. Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8 [ Time Frame: 8 hours ]
    Area under the Glucose Infusion Rate (GIR) time curve from 0 to 8 hours

  5. Assessment of PD parameter:GIR-max [ Time Frame: 8 hours ]
    Maximum smoothed GIR

  6. Assessment of PD parameter:GIR-tmax [ Time Frame: 8 hours ]
    Time to reach GIR-max

  7. Duration of blood glucose control [ Time Frame: 8 hours ]
    Duration of blood glucose control at or below 105 mg/dL

  8. Adverse Events [ Time Frame: Up to Day 62 ]
    Number of participants with adverse events



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
  • Total insulin dose of <1.0 U/kg/day
  • Fasting serum C-peptide <0.30 nmol/L at screening
  • Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening
  • Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study).
  • Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L
  • Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive

Exclusion criteria:

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II)
  • More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, 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
  • If female, pregnancy (defined as positive β-HCG blood test), breast-feeding

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): NCT03903016


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
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Germany
Investigational Site Number 2760001 Recruiting
Neuss, Germany, 41460
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: NCT03903016     History of Changes
Other Study ID Numbers: BEQ15846
2018-003131-30 ( EudraCT Number )
U1111-1207-8959 ( Other Identifier: UTN )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.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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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