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TOFO Insulin Combination Trial

10. oktober 2017 opdateret af: Sanofi

A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus

Primary Objectives:

To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus.

To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.

Secondary Objectives:

To assess the effects of tofogliflozin in comparison to placebo on:

  • Body weight
  • Fasting plasma glucose (FPG)
  • Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

211

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Adachi-ku, Japan
        • Investigational Site Number 392-028
      • Atsugi-shi, Japan
        • Investigational Site Number 392-007
      • Chuoh-ku, Japan
        • Investigational Site Number 392-026
      • Fukuoka-shi, Japan
        • Investigational Site Number 392-021
      • Ichihara-shi, Japan
        • Investigational Site Number 392-002
      • Iruma-shi, Japan
        • Investigational Site Number 392-012
      • Kawaguchi-shi, Japan
        • Investigational Site Number 392-003
      • Kitakyusyu-shi, Japan
        • Investigational Site Number 392-014
      • Kobe-shi, Japan
        • Investigational Site Number 392-027
      • Koga-shi, Japan
        • Investigational Site Number 392-004
      • Kunitachi-shi, Japan
        • Investigational Site Number 392-022
      • Kurume-shi, Japan
        • Investigational Site Number 392-019
      • Kyoto-shi, Japan
        • Investigational Site Number 392-001
      • Kyoto-shi, Japan
        • Investigational Site Number 392-024
      • Matsudo-shi, Japan
        • Investigational Site Number 392-006
      • Mito-shi, Japan
        • Investigational Site Number 392-008
      • Musashino-shi, Japan
        • Investigational Site Number 392-030
      • Okayama-shi, Japan
        • Investigational Site Number 392-029
      • Otsu-shi, Japan
        • Investigational Site Number 392-017
      • Sagamihara-shi, Japan
        • Investigational Site Number 392-011
      • Sakai-shi, Japan
        • Investigational Site Number 392-020
      • Sapporo-shi, Japan
        • Investigational Site Number 392-010
      • Sendai-shi, Japan
        • Investigational Site Number 392-016
      • Shinjuku-ku, Japan
        • Investigational Site Number 392-018
      • Shizuoka-shi, Japan
        • Investigational Site Number 392-005
      • Suita-shi, Japan
        • Investigational Site Number 392-031
      • Sumida-ku, Japan
        • Investigational Site Number 392-015
      • Sunto-gun, Japan
        • Investigational Site Number 392-023
      • Tokorozawa-shi, Japan
        • Investigational Site Number 392-013
      • Yokohama-shi, Japan
        • Investigational Site Number 392-025

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

20 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).
  • Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL.
  • Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.
  • Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.
  • Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.
  • Body mass index (BMI) ≥18.5 kg/m^2 and <35.0 kg/m^2.
  • No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.

Exclusion criteria:

  • Type 1 diabetes mellitus.
  • Pregnancy or lactation.
  • Severely uncontrolled glycemic situation.
  • History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.
  • History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.
  • A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility.
  • Has previously received treatment with the investigational product.
  • Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.
  • Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical [skin] application, eye drops and sprays).
  • Patients who are frequently experiencing orthostatic hypotension.
  • Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:
  • Lipid-lowering drug
  • Antihypertensive drug
  • Thyroid hormone preparation
  • Uric acid lowering drug

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: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: tofogliflozin
Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.
Medicin: TOFOGLIFLOZIN CSG452
Pharmaceutical form:tablet Route of administration: oral
Andre navne:
  • Apleway
  • Deberza
Medicin: insulin
Pharmaceutical form:solution Route of administration: subcutaneous
Placebo komparator: placebo
Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.
Medicin: TOFOGLIFLOZIN CSG452
Pharmaceutical form:tablet Route of administration: oral
Andre navne:
  • Apleway
  • Deberza
Medicin: insulin
Pharmaceutical form:solution Route of administration: subcutaneous
Medicin: placebo
Pharmaceutical form:tablet Route of administration: oral

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in HbA1c from baseline
Tidsramme: 16 weeks after first intake of investigational product
16 weeks after first intake of investigational product

Sekundære resultatmål

Resultatmål
Tidsramme
Change of Body Weight (BW) from baseline
Tidsramme: 16 weeks after first intake of investigational product
16 weeks after first intake of investigational product
Change of FPG from baseline
Tidsramme: 16 weeks after first intake of investigational product
16 weeks after first intake of investigational product
Change of PPG from baseline
Tidsramme: 16 weeks after first intake of investigational product
16 weeks after first intake of investigational product
Number of subjects with adverse events
Tidsramme: Up to 52 weeks from the first intake of investigational medicinal product
Up to 52 weeks from the first intake of investigational medicinal product

Samarbejdspartnere og efterforskere

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

Sponsor

Sanofi

Samarbejdspartnere

Kowa Company, Ltd.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. juni 2014

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

23. juli 2014

Først indsendt, der opfyldte QC-kriterier

23. juli 2014

Først opslået (Skøn)

25. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TOFOGL07061
  • U1111-1159-5316 (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 2 diabetes mellitus

Kliniske forsøg med TOFOGLIFLOZIN CSG452

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uruguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner