Organization Program of DiabEtes INsulIN ManaGement

Phase 4

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Structured Education; Behavioral: Conventional Diabetes Education; Drug: Scilin®M30

• Registration Number: NCT01338376
• Lead Sponsor: Chinese Diabetes Society

Brief 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.

Detailed 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 Timeline

• Study Start: 2011-03
• Status Verified: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12
• Primary Completion: 2012-03
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Written Informed Consent obtained before any trial-related activities Type 2 DM subjects;
• Age > 18 years old,male or female;
• Continuous treated with two or more oral antidiabetic drugs (OADs) for the last 3 months,and the current HbA1c>7.5%;
• Cooperative with structured management;

Exclusion Criteria

• Subjects with type 1 diabetes;
• Gestational diabetes mellitus and other specific types DM;
• Those who are unwilling to sign in ICF;
• Subjects with repeated hypoglycemia;
• Subjects with BMI>30kg/m2;
• Impaired liver function,defined as alanine aminotransferase (ALAT)>= 2.5 or alkaline phosphatase (ALP)>= 2 times upper referenced limit times upper normal limit;
• Females of childbearing age who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial (adequate contraceptive measures as required by local law or practice);
• Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation;
• Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, myocardial infarction within the past 12 months; severe neurology or psychology or psychiatric diseases; serious infection; actively disseminated intravascular coagulation;
• Malignant neoplastic diseases (except carcinoma in situ);
• Current addiction to alcohol or other addictive substances;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured Education Group	Structured Education	Subjects received structured diabetes education
Conventional Care Group:	Scilin®M30	Subjects received conventional diabetes education
Structured Education Group	Scilin®M30	Subjects received structured diabetes education
Conventional Care Group:	Conventional Diabetes Education	Subjects received conventional diabetes education

Primary Outcome Measures

Name	Time	Method
HbA1c	Screen,16weeks	Investigate glycemic control as measured by HbA1c change

Secondary Outcome Measures

Name	Time	Method
The incidence of Hypoglycemia	1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks
Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES)	Screen,16weeks
Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA)	Screen,16weeks
The satisfaction degree of structured management	Screen,2weeks,4weeks,8weeks,12weeks,16weeks
total daily insulin dose	1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks
7-points of glucose	Screen,16weeks	glucose before breakfast;glucose two hours after breakfast;glucose before lunch;glucose two hours after lunch;glucose before dinner;glucose two hours after dinner;glucose before sleep
body weight	baseline,2weeks,4weeks,8weeks,12weeks,16weeks
Medication compliance	Screen,16weeks

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China