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A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

5. marts 2019 opdateret af: Astellas Pharma Inc

Phase III Study of ASP1941 Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study consists of two parts. In Part 1, ASP1941 or placebo will be administered orally in a blind manner. In Part 2, the long-term safety and efficacy of ASP1941 will be evaluated in patients who have participated in the study and completed the Part 1.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

175

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Aichi, Japan
        • Site JP00005
      • Aichi, Japan
        • Site JP00028
      • Chiba, Japan
        • Site JP00003
      • Chiba, Japan
        • Site JP00013
      • Chiba, Japan
        • Site JP00035
      • Fukuoka, Japan
        • Site JP00023
      • Fukuoka, Japan
        • Site JP00022
      • Fukuoka, Japan
        • Site JP00031
      • Gunma, Japan
        • Site JP00011
      • Gunma, Japan
        • Site JP00002
      • Hiroshima, Japan
        • Site JP00006
      • Hokkaido, Japan
        • Site JP00033
      • Hokkaido, Japan
        • Site JP00034
      • Hyogo, Japan
        • Site JP00021
      • Ibaraki, Japan
        • Site JP00009
      • Ibaraki, Japan
        • Site JP00010
      • Kanagawa, Japan
        • Site JP00004
      • Kanagawa, Japan
        • Site JP00015
      • Kanagawa, Japan
        • Site JP00016
      • Mie, Japan
        • Site JP00019
      • Nagasaki, Japan
        • Site JP00008
      • Nagasaki, Japan
        • Site JP00024
      • Nagasaki, Japan
        • Site JP00025
      • Nagasaki, Japan
        • Site JP00032
      • Niigata, Japan
        • Site JP00026
      • Osaka, Japan
        • Site JP00036
      • Osaka, Japan
        • Site JP00029
      • Osaka, Japan
        • Site JP00020
      • Saitama, Japan
        • Site JP00012
      • Shizuoka, Japan
        • Site JP00018
      • Shizuoka, Japan
        • Site JP00017
      • Tochigi, Japan
        • Site JP00001
      • Tokushima, Japan
        • Site JP00030
      • Tokyo, Japan
        • Site JP00014
      • Toyama, Japan
        • Site JP00027
      • Yamaguchi, Japan
        • Site JP00007

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • The subject has been diagnosed with type 1 diabetes mellitus
  • The subject has been receiving insulin therapy for the treatment of diabetes mellitus.
  • The subject has not switched from an insulin product to another insulin product or switched between continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI).
  • The subject has an HbA1c value between 7.5% and 11.0% and the difference of HbA1c value is within ± 2.0%.
  • The subject has a fasting blood C-peptide level < 0.6 ng/mL.
  • The subject has a body mass index (BMI) between 20.0 kg/m2 and 35.0 kg/m2.

Exclusion Criteria:

  • The subject has type 2 diabetes mellitus.
  • The subject has participated in a clinical study or post marketing study of another drug or medical equipment within 12 weeks (84 days) before providing written informed consent, or is currently participating in such a study.
  • The subject has received treatment with ASP1941 (ipragliflozin) or participated in a clinical study of ASP1941 (excluding subjects who discontinued before the investigational period).
  • The subject participated in this study previously.
  • The subject has received a hypoglycemic agent other than insulin or an α-glucosidase inhibitor.
  • The subject has proliferative retinopathy (except for those who have undergone photocoagulation etc. and whose symptoms are stable).
  • The subject has experienced severe hypoglycemia.
  • The subject has experienced diabetic ketoacidosis.
  • The subject has chronic disease that requires the continuous use of corticosteroids, immunosuppressants, etc.
  • The subject has symptomatic urinary tract infection or symptomatic genital infection.
  • The subject has a history of recurrent urinary tract infection or recurrent genital infection.
  • The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or another serious heart disease.
  • The subject has a concomitant malignant tumor or a history of malignant tumor
  • The subject has a history of an allergy to ASP1941 (ipragliflozin) and/or similar drugs (drugs possessing SGLT2 inhibitory action).
  • The subject has psychiatric disorder that is inappropriate for participation in the study.
  • The subject has drug addiction or alcohol abuse.
  • The subject has severe infection or serious trauma, or is perioperative.
  • The subject has a history of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.
  • The subject has any symptoms of dysuria, anuria, oliguria, or urinary retention.
  • The subject has severe renal impairment or end-stage renal failure requiring dialysis.
  • The subject has an Aspartate Aminotransferase and/or Alanine Aminotransferase value that exceeds 2 times, or a total bilirubin value that exceeds 1.5 times the upper limit of the reference range.
  • The subject has uncontrolled severe hypertension.
  • The subject has serious gastrointestinal disease or a history of operation for serious gastrointestinal disease.

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: Part 1 ASP1941
ASP1941 will be administered for 24 weeks under double blind conditions.
Medicin: ipragliflozin
Oral administration once daily
Andre navne:
  • ASP1941
Andet: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
Placebo komparator: Part 1 Placebo
Placebo will be administered for 24 weeks under double blind conditions.
Medicin: Placebo
Oral administration én gang dagligt
Andet: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
Eksperimentel: Part 2 ASP1941
ASP1941 will be administered for 28 weeks under open label conditions.
Medicin: ipragliflozin
Oral administration once daily
Andre navne:
  • ASP1941
Andet: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in HbA1c
Tidsramme: Baseline and Week 24 (end of treatment period 1)
Baseline and Week 24 (end of treatment period 1)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sikkerhed vurderet ved forekomst af uønskede hændelser
Tidsramme: Op til uge 56
Op til uge 56
Change from baseline in HbA1c
Tidsramme: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in Fasting plasma glucose
Tidsramme: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in self-monitored blood glucose level
Tidsramme: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in leptin
Tidsramme: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in glycoalbumin
Tidsramme: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in adiponectin
Tidsramme: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in glucagon
Tidsramme: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in number of units of insulin administered concomitantly
Tidsramme: Baseline and up to Week 56
Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose.
Baseline and up to Week 56
Change from baseline in body weight
Tidsramme: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in waist circumference
Tidsramme: Baseline and up to Week 52
Baseline and up to Week 52
Safety assessed by sitting blood pressure
Tidsramme: Up to Week 56
Up to Week 56
Safety assessed by sitting pulse rate
Tidsramme: Up to Week 56
Up to Week 56
Safety assessed by standard 12-lead electrocardiogram
Tidsramme: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Hematology
Tidsramme: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Biochemistry
Tidsramme: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Urinalysis
Tidsramme: Up to Week 56
Up to Week 56

Samarbejdspartnere og efterforskere

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

Sponsor

Astellas Pharma Inc

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.

Hjælpsomme links

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 (Faktiske)

29. august 2016

Primær færdiggørelse (Faktiske)

22. juli 2017

Studieafslutning (Faktiske)

15. marts 2018

Datoer for studieregistrering

Først indsendt

27. juli 2016

Først indsendt, der opfyldte QC-kriterier

7. september 2016

Først opslået (Skøn)

13. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1941-CL-6002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

IPD-delingstidsramme

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD-delingsadgangskriterier

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

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 mellitus

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Saint Lucia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner