Organization Program of DiabEtes INsulIN ManaGement — OPENING  

Type 2 Diabetes Mellitus Clinical Trial

Official title: Organization Program of DiabEtes INsulIN ManaGement: An Open, Multi-center, Prospective, Randomized, 16-week, Controlled Clinical Study

Status Recruiting

Clinical Trial Summary

Diabetes is a common, costly condition associated with significant morbidity and mortality. Diabetes self-management education, the process of teaching individuals to manage their diabetes, has been considered an important part. The intensive education has the capacity to deliver effective interventions to a large number of people. The investigators may be able to redirect our efforts to diabetes care and education strategies that will have a positive impact on the optimization of glycemic control and the prevention of long-term complications of diabetes, reducing the subsequent human and health care costs.

Clinical Trial Description

This is a prospective, randomized, open-label, controlled clinical study. 1500 subjects with Type 2 DM will be enrolled and be randomized into Structured Education Group and Conventional Education Group in 1:1 ratio. Subjects in both of the groups will be treated with Scilin®M30 twice daily (30 minutes before breakfast and dinner). All the previous oral antidiabetic drugs (OAD(s)) will be discontinued except metformin and alpha-Glucosidase Inhibitors. The physician will determine the starting dose (0.3 IU/kg～0.4IU/kg), as well as later changes to dose according to insulin titration algorithm. The treatment duration will last 16 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT01338376
• Study type: Interventional
• Source: Chinese Diabetes Society
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2011
• Completion date: May 2012