Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Evaluation of Effectiveness of Treatment Paradigm for Newly Diagnosed Type 2 Diabetes Patients in China (NEW2D)

13. februar 2013 oppdatert av: China Cardiometabolic Registries

Evaluation of Effectiveness of Treatment Paradigm for Newly Diagnosed Type 2 Diabetes Patients in China (NEW2D STUDY) A Study Of China Cardiometabolic Registries (CCMR)

This is a study to gain better understanding on how those patients who are newly diagnosed with type 2 diabetes are treated and monitored. The study will record information such as type of therapy, therapeutic outcomes, and patients' satisfaction.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

The prevalence of diabetes around the world has increased from 30 million in 1985 to the current 235 million, and is expected to grow to 300 million in 2030, with more than 75 percent occurring in countries such as India and China. In China, economic prosperity and changes in diet and lifestyles have resulted in steep increase in prevalence of overweight, obesity, and diabetes. According to the latest study, in adults of 20 years of age or older, the incidence of diabetes has reached 9.7% and the prevalence 92.4 million. In a nationwide, cross over cohort study that was recently completed in China, the results showed that the duration of diabetes is positively correlated with the incidence of CAD and all microvascular diabetic complications. Preventing diabetes progression and preventing the onset of cardiovascular diseases early on at the stage of newly diagnosis is thus one of the most important goals in managing type 2 diabetes.

According to the Chinese Guidelines for Prevention and Treatment of Diabetes, which is consistent with IDF Clinical Guidelines Task Force Global Guideline for Type 2 Diabetes, the therapeutic target for type 2 diabetes is defined as HbA1C < 6.5%. Various national surveys conducted in China in 2003, 2004, 2006 have shown that only about one forth of type 2 diabetes patients in China reached this therapeutic target.Over the recent few years, a number of new antidiabetic treatments, such as DPP-IV inhibitors, have been introduced to the real world practice of diabetes management in China, creating exciting opportunities to potentially improve glycemic control. UKPDS (United Kingdom Prospective Diabetes Study) provided the evidence for improving glycemic control through aggressive treatment in western population. There is now substantial evidence on management of patients with type 2 diabetes. However, it is believed that not all patients have benefited from optimal diabetes management in China, partially due to diversity of standards of clinical practices and complexity of diabetes care itself. For example, it is unclear which treatment regimen works more effectively for managing newly diagnosed type 2 diabetes patients or whether a more aggressive strategy be used during the early stage of treatment. Moreover, it remains answering that what other factors may influence the treatment outcomes. There are clearly significant unmet needs and thus significant opportunities to leverage the existing medical advancement.

This study is thus designed to evaluate current treatment patterns and treatment outcomes for managing newly diagnosed type 2 diabetes patients and to assess specific unmet needs, influencing factors, management platforms, and gaps and trends in practice, providing a comprehensive knowledge in current management of newly diagnosed diabetes and insight on opportunities and strategy for future research and development of improved therapy.

Studietype

Observasjonsmessig

Registrering (Forventet)

5000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Beijing, Kina
        • People's Hospital of Peking University
      • Xian, Kina
        • Xijing Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Subjects seen at outpatient clinics of tier 1, 2, and 3 hospitals across the 6 major geographic regions

Beskrivelse

  • 20 years of age or older
  • Confirmed diagnosis of type 2 diabetes made within past 6 months according to the 2010 Chinese Guideline for Type 2 diabetes
  • Have not received any pharmacological treatment for T2D, or have started on one regimen and have not switched or added any other hypoglycemic agent
  • Have completed a lab test +/- 30 days of the baseline visit or is due for a lab evaluation including HbA1C, serum glucose, lipid profile, and other routine tests
  • Willing to return for all follow up visits.

Exclusion Criteria:

  • Patients who are not willing or not able to return to the same hospital for follow up visits every 3 months for one year after enrollment (e.g. do no reside locally)
  • Patients who are participating in another interventional clinical trials
  • Patients who are not willing to sign informed consent form

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Diagnosed within 6 months
No (test) intervention to be adminisitered

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The primary endpoint of this study is the overall proportion of patients whose HbA1c is less than 6.5%, measured at the end of one year follow up.
Tidsramme: 12 months
12 months

Sekundære resultatmål

Resultatmål
Tidsramme
The proportions of patients receiving various regimen, and the duration of each regimen
Tidsramme: 12 months
12 months
The clinical effectiveness of each regimen measured by the proportion of patients reaching the target glycemic control
Tidsramme: 12 months
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2012

Primær fullføring (Forventet)

1. oktober 2013

Studiet fullført (Forventet)

1. januar 2014

Datoer for studieregistrering

Først innsendt

1. februar 2012

Først innsendt som oppfylte QC-kriteriene

2. februar 2012

Først lagt ut (Anslag)

3. februar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. februar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. februar 2013

Sist bekreftet

1. februar 2012

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Type 2 diabetes

3
Abonnere