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

21. oktober 2014 opdateret af: Sanofi

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Frankfurt, Tyskland
        • Sanofi Administrative Office

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Test (T)
SAR342434: single dose injection
Medicin: SAR342434
Pharmaceutical form:solution Route of administration: subcutaneous
Aktiv komparator: Reference 1 (R1)
US-approved Humalog®: single dose injection
Medicin: Insulin Lispro
Pharmaceutical form:solution Route of administration: subcutaneous
Aktiv komparator: Reference 2 (R2)
EU-approved Humalog®: single dose injection
Medicin: Insulin Lispro
Pharmaceutical form:solution Route of administration: subcutaneous

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog
Tidsramme: 12 hours
12 hours
Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog
Tidsramme: 12 hours
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)
Tidsramme: 12 hours
12 hours

Sekundære resultatmål

Resultatmål
Tidsramme
The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)
Tidsramme: 12 hours
12 hours
Time to 20% of AUC (t20%-AUC)
Tidsramme: 12 hours
12 hours
NS-tmax, INS-t1/2z
Tidsramme: 12 hours
12 hours
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)
Tidsramme: 12 hours
12 hours
Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)
Tidsramme: 12 hours
12 hours
Maximum smoothed body weight standardized GIR (GIRmax)
Tidsramme: 12 hours
12 hours
Time to GIRmax (GIR-tmax)
Tidsramme: 12 hours
12 hours
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)
Tidsramme: 12 hours
12 hours
Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia
Tidsramme: 8 weeks
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2013

Primær færdiggørelse (Faktiske)

1. juli 2013

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

21. oktober 2014

Først indsendt, der opfyldte QC-kriterier

21. oktober 2014

Først opslået (Skøn)

23. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PDY12704
  • 2012-004453-86
  • U1111-1134-4816 (Anden identifikator: UTN)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 1 diabetes

Kliniske forsøg med SAR342434

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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