Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus on SGLT 2 Inhibitor Therapy in Singapore

29 décembre 2019 mis à jour par: AstraZeneca

SGLT2 Inhibitor Registry in Singapore

To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly used hypoglycaemic drugs in real life clinical settings.

To evaluate real life clinical effectiveness and safety of Sodium-Glucose Co-Transporter inhibitor- 2 in Singaporean Type 2 diabetes mellitus patients treated on an outpatient basis in clinical practice setting. The study would also assess treatment patterns with SGLT2 inhibitor patient relevant outcomes in whole population as well as pre identified patient subgroups.

Primary analysis to be done at 1 year and extended analysis at 2 years.

Aperçu de l'étude

Statut

Complété

Les conditions

Diabète sucré

Description détaillée

T2DM is associated with overweight/obesity and high fasting plasma glucose (FPG) in White patients, whereas Asian patients are more predisposed to high abdominal fat distribution and high postprandial glucose (PPG) levels, thought to contribute1-4. In response to identical meals, Asian subjects exhibit greater glycemic response than do White subjects4,5. According to the Diabetic Society of Singapore, one out of nine people aged 18 to 69 has diabetes, that's about 11.3% of the population or more than 400,000 people & this is expected to rise with the increasing prevalence of a sedentary lifestyle and high-calorie dietary intake.

SGLT2 inhibitors offers a novel insulin-independent approach to lowering hyperglycaemia and improving metabolic control of type 2 diabetes: they reduce renal glucose reabsorption by inhibition of SGLT2 transporters in the proximal tubule of the kidney, resulting in urinary glucose excretion. Since SGLT2 inhibition is independent of β-cell function or insulin sensitivity, this treatment approach could have applications throughout the natural history of diabetes.6

The reductions in fasting plasma glucose concentration and bodyweight during the treatment with the SGLT2 i, are sustained. Early weight loss, is partly due to a mild osmotic diuresis caused by SGLT2 I, however, the gradual progressive reduction in bodyweight thereafter, with decreased waist circumference, is consistent with a reduction of fat mass. This reduction is potentially attributable to the loss of excess energy through glucose excretion in the urine, an effect supported by the increased urinary glucose/creatinine ratio in patients assigned to SGLT2i.6

Many trials shows that SGLT2 i can improve glycaemic control in patients who have inadequate control with metformin. The drug acts independently of insulin, lowers weight, and is not associated with risk of hypoglycaemia. Safety and tolerability of the drugs were also confirmed. Therefore, addition of SGLT2i to metformin provides a new therapeutic option for treatment of type 2 diabetes.6

Data collection will be done by AZ medical personnel or Pharmacy interns, it will be a paper data collection and will be handed over to the CRO company for data entry & analysis..Data analysis will be done by an independent CRO company namely BioQuest Solutions.

Type d'étude

Observationnel

Inscription (Réel)

201

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

Singapour
- - Singapore, Singapour
    - Research Site

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 à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Simple random sample.

La description

Inclusion Criteria:

Patients should meet all of the following criteria at Day 0:

Outpatient equal to or more than 18 years of age
Diagnosed as T2DM and treated with antidiabetic medicines at least 3 months and suitable for SGLT2 inhibitor as current treatment judged by PI with HbA1c > 7.0 %
Will provide completed and signed written informed consents Each participating investigator, will be asked to recruit a fixed number of patients ranging from 10 to 40 depending on site specificities.

Exclusion Criteria:

Patients, with the following criteria will be excluded at Day 0:

Hypersensitivity to any SGLT2 inhibitor or any of the components in the formulation
Patients with Type 1 diabetes
Female patients with gestational diabetes during pregnancy
Female patients who are pregnant, intending to become pregnant or breastfeeding
Severe medical condition(s) that in the view of the investigator prohibits participation in the study e.g. cancer, end stage liver disease, end stage renal failure (non-diabetes related)
Use of other investigational drugs at the time of enrolment
Renal Function: <30ml/min/1.73m2

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: Cas uniquement
Perspectives temporelles: Éventuel

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change from baseline in the HbA1c level after 1 year Délai: baseline to 1 year	to assess whether the therapy initiated with SGLT2 inhibitors at baseline is able to reduce the HbA1c after 1 year.	baseline to 1 year

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Change from baseline in FPG level at 6months Délai: Blood samples are collected pre-dose, 6 months post-dose	By assessment of the other lipid level reduction from baseline lab value to the last lab value	Blood samples are collected pre-dose, 6 months post-dose
Change from baseline in FPG level at 12months Délai: Blood samples are collected pre-dose, 12 months post-dose	By assessment of the other lipid level reduction from baseline lab value to the last lab value	Blood samples are collected pre-dose, 12 months post-dose
Change from baseline in weight at 6months Délai: weight is measured pre-dose, 6 months post-dose	By assessment of the other weight reduction from baseline value to the last value	weight is measured pre-dose, 6 months post-dose
Change from baseline in weight at 12 months Délai: weight is measured pre-dose, 12 months post-dose	By assessment of the other weight reduction from baseline value to the last value	weight is measured pre-dose, 12 months post-dose
Change from baseline in BP at 6 months Délai: BP is measured pre-dose, 6 months post-dose	By assessment of the other BP reduction from baseline value to the last value	BP is measured pre-dose, 6 months post-dose
Change from baseline in BP at 12 months Délai: BP is measured pre-dose, 12 months post-dose	By assessment of the other BP reduction from baseline value to the last value	BP is measured pre-dose, 12 months post-dose
Change from baseline in Lipids at 6 months Délai: Blood samples are collected pre-dose, 6 months post-dose	By assessment of the other lipid level reduction from baseline lab value to the last lab value	Blood samples are collected pre-dose, 6 months post-dose
Change from baseline in Lipids at 12 months Délai: Blood samples are collected pre-dose, 12 months post-dose	By assessment of the other lipid level reduction from baseline lab value to the last lab value	Blood samples are collected pre-dose, 12 months post-dose
Change from baseline in Waist circumference at 6 months Délai: waist circumference is measured pre-dose, 6 months post-dose	By assessment of the other waist circumference reduction from baseline value to the last value	waist circumference is measured pre-dose, 6 months post-dose
Change from baseline in Waist circumference at 12 months Délai: waist circumference is measured pre-dose, 12 months post-dose	By assessment of the other waist circumference reduction from baseline value to the last value	waist circumference is measured pre-dose, 12 months post-dose

Collaborateurs et enquêteurs

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

Parrainer

AstraZeneca

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.

Publications générales

REFERENCES 1. Wang JS, et al. Diabetes Metab Res Rev. 2011;27:79-84 2. Bonora E, et al. Diabetes Care. 2001;24:2023-2029 3. Peter R, et al. Diabet Med. 2006;23:990-995 4. Venn BS, et al. Diabet Med. 2010;27:1205-1208 5. Henry CJ, et al. Br J Nutr. 2008;99:840-845 6. Bailey CJ, et al. Lancet. 2010;375:2223-33

Liens utiles

CSR Synopsis

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)

12 février 2016

Achèvement primaire (Réel)

31 décembre 2018

Achèvement de l'étude (Réel)

31 décembre 2018

Dates d'inscription aux études

Première soumission

29 septembre 2015

Première soumission répondant aux critères de contrôle qualité

16 octobre 2015

Première publication (Estimation)

19 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 janvier 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 décembre 2019

Dernière vérification

1 décembre 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

D1843R00258

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 .