Jikei Optimal Insulin Therapy in Type 2 Diabetes

Not Applicable

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00348231
• Lead Sponsor: Jikei University School of Medicine

Brief Summary

The purpose of this study is to compare whether there is the difference in the effect of insulin therapy by the number of times of insulin injection.

Detailed Description

The current insulin therapy is divided into the conventional insulin therapy (1\~2 injections per day) and the intensive insulin therapy (3\~4 injections per day). The kinetics of exogenous insulin in the intensive insulin therapy imitate the kinetics of insulin secretion in a healthy person. A previous large clinical study (e.g. DCCT, Kumamoto study, etc.) suggested that intensive insulin therapy prevented microangiopathy and macroangiopathy, and inhibited progression of them, however many patients chose conventional insulin therapy because many hoped that they injected insulin as few as possible. The patients thought that their life styles were disturbed by many times of insulin injection.

The current dual-acting insulin made from insulin as part modified by protamine is able to suppress postprandial hyperglycemia. The new insulin may possibly have the kinetics of insulin in the patient who uses insulin as the intensive insulin therapy. Moreover, the patients will receive the insulin therapy easily if the times of insulin injection are fewer. It may lead to perform the more effective insulin therapy to search for the optimal insulin therapy in induction in type 2 diabetes.

comparison:HbA1c, glycated albumin, IMT, lipid profile,body weight, daily profile of blood glucose,between the conventional insulin therapy and the intensive insulin therapy.

Study Timeline

• Study Start: 2004-11
• Status Verified: 2006-06
• Study First Submitted: 2006-07-03
• Study First Submitted QC: 2006-07-03
• Study First Posted: 2006-07-04
• Study Completion: 2006-08
• Last Update Submitted: 2006-08-31
• Last Update Posted: 2006-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of Type 2 diabetes
• secondary failure of SU drug
• whose age is to 80 from 20 years old

Exclusion Criteria

• who has the complication
• who has a allergy of insulin
• who is pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c
daily profile of blood glucose

Secondary Outcome Measures

Name	Time	Method
IMT
QOL

Trial Locations

Locations (1)

The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicine; 🇯🇵 Tokyo, Japan