Organization Program of DiabEtes INsulIN ManaGement

Type 2 Diabetes Mellitus Clinical Trial

— OPENING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01338376
• Other study ID #: Scilin20110124
• Status: Recruiting
• Phase: Phase 4
• First received: April 15, 2011
• Last updated: October 10, 2011
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2011
• Source: Chinese Diabetes Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Behavioral:
• Structured Education
All of the educators who are responsible for the intensive group will be trained with the standard contents before the study kick-off. Educator Activities: insulin injection, SMBG instruction, self-learned manuals, periodic assessment for subjects, subject counseling, self-care education (healthy eating, exercise, weight control), prevention and treatment of hypoglycemia complication education ,newsletter delivered by SMS Physician Activity: frequent insulin titration
• Conventional Diabetes Education
The activities of the educators who are responsible for conventional group are identical with their routine clinical practice. Educator Activities: insulin injection, SMBG instruction, healthy eating , prevention and treatment of hypoglycemia Physician Activity: less frequent insulin titration

Drug:
• Scilin®M30
Subjects will be treated with Scilin®M30 twice daily

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Diabetes Society

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Investigate glycemic control as measured by HbA1c change	Screen,16weeks	No
Secondary	Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES)		Screen,16weeks	No
Secondary	Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA)		Screen,16weeks	No
Secondary	The satisfaction degree of structured management		Screen,2weeks,4weeks,8weeks,12weeks,16weeks	No
Secondary	total daily insulin dose		1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks	No
Secondary	7-points of glucose	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	Screen,16weeks	No
Secondary	body weight		baseline,2weeks,4weeks,8weeks,12weeks,16weeks	No
Secondary	Medication compliance		Screen,16weeks	No
Secondary	The incidence of Hypoglycemia		1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks	Yes