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

29. Dezember 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

201

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Singapore, Singapur
        • Research Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Simple random sample.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Nur Fall
  • Zeitperspektiven: Interessent

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in the HbA1c level after 1 year
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in FPG level at 6months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

  • 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

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Februar 2016

Primärer Abschluss (Tatsächlich)

31. Dezember 2018

Studienabschluss (Tatsächlich)

31. Dezember 2018

Studienanmeldedaten

Zuerst eingereicht

29. September 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Oktober 2015

Zuerst gepostet (Schätzen)

19. Oktober 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Dezember 2019

Zuletzt verifiziert

1. Dezember 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • D1843R00258

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