Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

29 december 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

201

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Singapore, Singapore
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Simple random sample.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Endast fall
  • Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in the HbA1c level after 1 year
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in FPG level at 6months
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 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

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 februari 2016

Primärt slutförande (Faktisk)

31 december 2018

Avslutad studie (Faktisk)

31 december 2018

Studieregistreringsdatum

Först inskickad

29 september 2015

Först inskickad som uppfyllde QC-kriterierna

16 oktober 2015

Första postat (Uppskatta)

19 oktober 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 januari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 december 2019

Senast verifierad

1 december 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • D1843R00258

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Diabetes mellitus

3
Prenumerera