- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02201004
TOFO Insulin Combination Trial
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
Adachi-ku, Japon
- Investigational Site Number 392-028
-
Atsugi-shi, Japon
- Investigational Site Number 392-007
-
Chuoh-ku, Japon
- Investigational Site Number 392-026
-
Fukuoka-shi, Japon
- Investigational Site Number 392-021
-
Ichihara-shi, Japon
- Investigational Site Number 392-002
-
Iruma-shi, Japon
- Investigational Site Number 392-012
-
Kawaguchi-shi, Japon
- Investigational Site Number 392-003
-
Kitakyusyu-shi, Japon
- Investigational Site Number 392-014
-
Kobe-shi, Japon
- Investigational Site Number 392-027
-
Koga-shi, Japon
- Investigational Site Number 392-004
-
Kunitachi-shi, Japon
- Investigational Site Number 392-022
-
Kurume-shi, Japon
- Investigational Site Number 392-019
-
Kyoto-shi, Japon
- Investigational Site Number 392-001
-
Kyoto-shi, Japon
- Investigational Site Number 392-024
-
Matsudo-shi, Japon
- Investigational Site Number 392-006
-
Mito-shi, Japon
- Investigational Site Number 392-008
-
Musashino-shi, Japon
- Investigational Site Number 392-030
-
Okayama-shi, Japon
- Investigational Site Number 392-029
-
Otsu-shi, Japon
- Investigational Site Number 392-017
-
Sagamihara-shi, Japon
- Investigational Site Number 392-011
-
Sakai-shi, Japon
- Investigational Site Number 392-020
-
Sapporo-shi, Japon
- Investigational Site Number 392-010
-
Sendai-shi, Japon
- Investigational Site Number 392-016
-
Shinjuku-ku, Japon
- Investigational Site Number 392-018
-
Shizuoka-shi, Japon
- Investigational Site Number 392-005
-
Suita-shi, Japon
- Investigational Site Number 392-031
-
Sumida-ku, Japon
- Investigational Site Number 392-015
-
Sunto-gun, Japon
- Investigational Site Number 392-023
-
Tokorozawa-shi, Japon
- Investigational Site Number 392-013
-
Yokohama-shi, Japon
- Investigational Site Number 392-025
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
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: tofogliflozin
Tofogliflozin administered once daily for 52 weeks.
Insulin administered as base treatment.
|
Pharmaceutical form:tablet Route of administration: oral
Autres noms:
Pharmaceutical form:solution Route of administration: subcutaneous
|
Comparateur placebo: placebo
Placebo administered once daily for 16 weeks.
After 16-weeks, Tofogliflozin administered once daily for 36 weeks.
Insulin administered as base treatment.
|
Pharmaceutical form:tablet Route of administration: oral
Autres noms:
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Change in HbA1c from baseline
Délai: 16 weeks after first intake of investigational product
|
16 weeks after first intake of investigational product
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Change of Body Weight (BW) from baseline
Délai: 16 weeks after first intake of investigational product
|
16 weeks after first intake of investigational product
|
Change of FPG from baseline
Délai: 16 weeks after first intake of investigational product
|
16 weeks after first intake of investigational product
|
Change of PPG from baseline
Délai: 16 weeks after first intake of investigational product
|
16 weeks after first intake of investigational product
|
Number of subjects with adverse events
Délai: Up to 52 weeks from the first intake of investigational medicinal product
|
Up to 52 weeks from the first intake of investigational medicinal product
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs du transporteur sodium-glucose 2
- 6-((4-éthylphényl)méthyl)-3',4',5',6'-tétrahydro-6'-(hydroxyméthyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3 ',4',5'-triol
Autres numéros d'identification d'étude
- TOFOGL07061
- U1111-1159-5316 (UTN)
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 .
Essais cliniques sur Diabète sucré de type 2
-
Bnai Zion Medical CenterInconnue
-
Jiangsu HengRui Medicine Co., Ltd.Complété
-
Asahi Kasei Pharma CorporationRecrutement
-
University of MinnesotaActif, ne recrute pasHypoglycémie | Diabète sucré de type 2États-Unis
-
University of Campania "Luigi Vanvitelli"ComplétéDiabète sucré de type 2Italie
-
University of LiverpoolAstraZeneca; Clinical Practice Research DatalinkActif, ne recrute pas
-
Regor Pharmaceuticals Inc.RésiliéDiabète sucré de type 2États-Unis
-
Charles Drew University of Medicine and ScienceNational Center for Research Resources (NCRR)Résilié
-
Population Health Research InstituteNovo Nordisk A/SComplétéDiabète sucré de type 2Canada
-
Northwell HealthPatient-Centered Outcomes Research InstituteComplétéDiabète sucré de type 2 | Diabète de type 2États-Unis
Essais cliniques sur TOFOGLIFLOZIN CSG452
-
Kowa Research Institute, Inc.Complété
-
Kowa Research Institute, Inc.RecrutementNASHÉtats-Unis, Canada, Espagne, Japon, Bulgarie
-
Kowa Research Institute, Inc.Complété