Organization Program of DiabEtes INsulIN ManaGement (OPENING)

Chinese Diabetes Society

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Scilin®M30; Behavioral: Conventional Diabetes Education; Behavioral: Structured Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01338376

Scilin20110124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Structured Education Group

Experimental group

Description:

Subjects received structured diabetes education

Treatment:

Drug: Scilin®M30

Behavioral: Structured Education

Conventional Care Group:

Active Comparator group

Description:

Subjects received conventional diabetes education

Treatment:

Drug: Scilin®M30

Behavioral: Conventional Diabetes Education