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

5 mars 2019 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

175

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Part 1 ASP1941
ASP1941 will be administered for 24 weeks under double blind conditions.
Médicament: ipragliflozin
Oral administration once daily
Autres noms:
  • ASP1941
Autre: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
Comparateur placebo: Part 1 Placebo
Placebo will be administered for 24 weeks under double blind conditions.
Médicament: Placebo
Administration orale une fois par jour
Autre: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
Expérimental: Part 2 ASP1941
ASP1941 will be administered for 28 weeks under open label conditions.
Médicament: ipragliflozin
Oral administration once daily
Autres noms:
  • ASP1941
Autre: Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Change from baseline in HbA1c
Délai: Baseline and Week 24 (end of treatment period 1)
Baseline and Week 24 (end of treatment period 1)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Innocuité évaluée par l'incidence des événements indésirables
Délai: Jusqu'à la semaine 56
Jusqu'à la semaine 56
Change from baseline in HbA1c
Délai: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in Fasting plasma glucose
Délai: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in self-monitored blood glucose level
Délai: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in leptin
Délai: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in glycoalbumin
Délai: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in adiponectin
Délai: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in glucagon
Délai: Baseline and up to Week 52
Baseline and up to Week 52
Change from baseline in number of units of insulin administered concomitantly
Délai: 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
Délai: Baseline and up to Week 56
Baseline and up to Week 56
Change from baseline in waist circumference
Délai: Baseline and up to Week 52
Baseline and up to Week 52
Safety assessed by sitting blood pressure
Délai: Up to Week 56
Up to Week 56
Safety assessed by sitting pulse rate
Délai: Up to Week 56
Up to Week 56
Safety assessed by standard 12-lead electrocardiogram
Délai: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Hematology
Délai: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Biochemistry
Délai: Up to Week 56
Up to Week 56
Safety assessed by laboratory tests: Urinalysis
Délai: Up to Week 56
Up to Week 56

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Astellas Pharma Inc

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 août 2016

Achèvement primaire (Réel)

22 juillet 2017

Achèvement de l'étude (Réel)

15 mars 2018

Dates d'inscription aux études

Première soumission

27 juillet 2016

Première soumission répondant aux critères de contrôle qualité

7 septembre 2016

Première publication (Estimation)

13 septembre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 mars 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mars 2019

Dernière vérification

1 mars 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1941-CL-6002

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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