Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
23 janvier 2019 mis à jour par: Takeda
A Prospective, Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or alogliptin FDCs, in standard clinical practice.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
The drug being studied in this study is called alogliptin and alogliptin FDCs. Alogliptin and alogliptin FDCs is being researched to treat people who have diabetes mellitus type 2. This study will look at the glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2.
The study enrolled 593 patients. Alogliptin and alogliptin FDCs will be prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study).
This multi-center study will be conducted in China. The overall duration of study for observation will be approximately 6 months, or up to loss to follow-up or death, whichever occurs first. Participants will make multiple visits to the clinic as per regular doctor's appointments.
Type d'étude
Observationnel
Inscription (Réel)
593
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
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Beijing
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Beijing, Beijing, Chine
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Hubei
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Wuhan, Hubei, Chine
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Liaoning
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Dalian, Liaoning, Chine
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Shenyang, Liaoning, Chine
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Shandong
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Jinan, Shandong, Chine
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Qingdao, Shandong, Chine
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Tai'an, Shandong, Chine
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Taian, Shandong, Chine
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Tianjin
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Tianjin, Tianjin, Chine
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Sai Ying Pun, Hong Kong
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Sha Tin, Hong Kong
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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
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.
La description
Inclusion Criteria:
- Has a diagnosis of T2DM.
- Has made the decision, along with his/her treating physician, to begin treatment with alogliptin or alogliptin fixed-dose combinations (FDCs).
- Has an glycated hemoglobin (HbA1c) value recorded at most 3 months before initiation of treatment with alogliptin or alogliptin FDCs.
- Alogliptin or alogliptin FDCs is prescribed according to the approved label for China and Hong Kong.
Exclusion Criteria:
- Has gestational diabetes or type 1 diabetes mellitus.
- Has used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of alogliptin or alogliptin FDCs treatment.
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
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
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Comprimés d'alogliptine
Alogliptin FDC with pioglitazone tablets
Alogliptin FDC with metformin tablets
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changement du taux d'hémoglobine glycosylée (HbA1c) par rapport au départ au mois 6
Délai: Ligne de base et mois 6
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La variation de la valeur de l'hémoglobine glycosylée (la concentration de glucose liée à l'hémoglobine en pourcentage du maximum absolu pouvant être lié) recueillie au mois 6 par rapport à la ligne de base.
L'hémoglobine glycosylée (HbA1c) en tant que critère diagnostique du diabète sucré est ≥ 6,5 %.
Un changement négatif par rapport au niveau de référence indique une amélioration.
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Ligne de base et mois 6
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
Délai: Baseline and Month 6
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The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline.
Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%.
Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control.
A negative change from Baseline indicates improvement.
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Baseline and Month 6
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Percentage of Participants With a Decrease in HbA1c Level by <7.0%
Délai: Baseline and Month 6
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Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.
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Baseline and Month 6
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Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
Délai: Baseline and Month 6
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Percentage of participants with a decrease of >0.3% from baseline in HbA1c along with no tolerability findings were reported.
Tolerability findings included hypoglycemic event, or weight gain ≥5%.
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Baseline and Month 6
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Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
Délai: Baseline and Months 3 and 6
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The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline.
A negative change from Baseline indicates improvement.
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Baseline and Months 3 and 6
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
Délai: Baseline and Months 3 and 6
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The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline.
A negative change from Baseline indicates improvement.
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Baseline and Months 3 and 6
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Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Délai: Baseline up to Month 6
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An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function.
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.
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Baseline up to Month 6
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Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs
Délai: Months 3 and 6
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Months 3 and 6
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Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
Délai: Months 3 and 6
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Months 3 and 6
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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)
22 décembre 2016
Achèvement primaire (Réel)
26 janvier 2018
Achèvement de l'étude (Réel)
26 janvier 2018
Dates d'inscription aux études
Première soumission
8 décembre 2016
Première soumission répondant aux critères de contrôle qualité
8 décembre 2016
Première publication (Estimation)
12 décembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 avril 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 janvier 2019
Dernière vérification
1 janvier 2019
Plus d'information
Termes liés à cette étude
Mots clés
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 d'enzymes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Inhibiteurs de protéase
- Incrétines
- Inhibiteurs de dipeptidyl-peptidase IV
- Metformine
- Pioglitazone
- Alogliptine
Autres numéros d'identification d'étude
- Alogliptin-5009
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime IPD
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach
for details).
To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias.
Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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 .