Evaluation of Effectiveness of Treatment Paradigm for Newly Diagnosed Type 2 Diabetes Patients in China (NEW2D)
Type 2 Diabetes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Effectiveness of Treatment Paradigm for Newly Diagnosed Type 2 Diabetes Patients in China (NEW2D STUDY) A Study Of China Cardiometabolic Registries (CCMR)|
- 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The proportions of patients receiving various regimen, and the duration of each regimen [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The clinical effectiveness of each regimen measured by the proportion of patients reaching the target glycemic control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Diagnosed within 6 months
No (test) intervention to be adminisitered
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525693
|People's Hospital of Peking University|
|Principal Investigator:||Linong Ji, MD||People's Hospital of Peking University|