Organization Program of DiabEtes INsulIN ManaGement (OPENING)

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Structured Education; Drug: Scilin®M30; Behavioral: Conventional Diabetes Education

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 Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Peking University First Hospital, 3A grade; Phone Number: +86 10 83572211; Email: dyyy@bddyyy.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Structured Education Group; Subjects received structured diabetes education	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; Drug: Scilin®M30; Subjects will be treated with Scilin®M30 twice daily
Active Comparator: Conventional Care Group: Subjects received conventional diabetes education	Drug: Scilin®M30; Subjects will be treated with Scilin®M30 twice daily; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Investigate glycemic control as measured by HbA1c change	Screen,16weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
body weight		baseline,2weeks,4weeks,8weeks,12weeks,16weeks
Medication compliance		Screen,16weeks
The incidence of Hypoglycemia		1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks

Collaborators and Investigators

• Sponsor: Chinese Diabetes Society
• Investigators: Principal Investigator: Guo Xiao Hui, Professor, Peking University First Hospital

Publications and helpful links

General Publications

• Guo XH, Ji LN, Lu JM, Liu J, Lou QQ, Liu J, Shen L, Zhang MX, Lv XF, Gu MJ. Efficacy of structured education in patients with type 2 diabetes mellitus receiving insulin treatment. J Diabetes. 2014 Jul;6(4):290-7. doi: 10.1111/1753-0407.12100. Epub 2013 Nov 26.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 10, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Scilin20110124