Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

5 maart 2019 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

175

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • 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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Part 1 ASP1941
ASP1941 will be administered for 24 weeks under double blind conditions.
Geneesmiddel: ipragliflozin
Oral administration once daily
Andere namen:
  • ASP1941
Ander: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
Placebo-vergelijker: Part 1 Placebo
Placebo will be administered for 24 weeks under double blind conditions.
Geneesmiddel: Placebo
Orale toediening eenmaal daags
Ander: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
Experimenteel: Part 2 ASP1941
ASP1941 will be administered for 28 weeks under open label conditions.
Geneesmiddel: ipragliflozin
Oral administration once daily
Andere namen:
  • ASP1941
Ander: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Veiligheid beoordeeld door incidentie van bijwerkingen
Tijdsspanne: Tot week 56
Tot week 56
Change from baseline in HbA1c
Tijdsspanne: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in Fasting plasma glucose
Tijdsspanne: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in self-monitored blood glucose level
Tijdsspanne: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in leptin
Tijdsspanne: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in glycoalbumin
Tijdsspanne: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in adiponectin
Tijdsspanne: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in glucagon
Tijdsspanne: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in number of units of insulin administered concomitantly
Tijdsspanne: 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
Tijdsspanne: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in waist circumference
Tijdsspanne: Baseline and up to Week 52
Baseline and up to Week 52
Safety assessed by sitting blood pressure
Tijdsspanne: Up to Week 56
Up to Week 56
Safety assessed by sitting pulse rate
Tijdsspanne: Up to Week 56
Up to Week 56
Safety assessed by standard 12-lead electrocardiogram
Tijdsspanne: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Hematology
Tijdsspanne: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Biochemistry
Tijdsspanne: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Urinalysis
Tijdsspanne: Up to Week 56
Up to Week 56

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Astellas Pharma Inc

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 augustus 2016

Primaire voltooiing (Werkelijk)

22 juli 2017

Studie voltooiing (Werkelijk)

15 maart 2018

Studieregistratiedata

Eerst ingediend

27 juli 2016

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2016

Eerst geplaatst (Schatting)

13 september 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 maart 2019

Laatste update ingediend die voldeed aan QC-criteria

5 maart 2019

Laatst geverifieerd

1 maart 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1941-CL-6002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • MVO

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren