Jikei Optimal Insulin Therapy in Type 2 Diabetes

NCT ID: NCT00348231

Last Updated: 2006-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2006-08-31

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, biphasic insulin analogue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

dual-action insulin analog

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Jikei University School of Medicine

OTHER

Sponsor Role: lead

Principal Investigators

Yumi Miyashita, MD

Role: PRINCIPAL_INVESTIGATOR

The Jikei University School of Medicine

Locations

The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicine

Tokyo, Tokyo, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Yumi Miyashita, MD

Role: CONTACT

Phone: +081334331111

Email: yumi-m@jikei.ac.jp

Facility Contacts

Yumi Miyawshita, MD

Role: primary

References

Miyashita Y, Nishimura R, Nemoto M, Matsudaira T, Kurata H, Yokota T, Yokota K, Tojo K, Utsunomiya K, Tajima N. Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure. Cardiovasc Diabetol. 2008 May 29;7:16. doi: 10.1186/1475-2840-7-16.

Reference Type: DERIVED

PMID: 18507868 (View on PubMed)

Other Identifiers

15-195(4220)

Identifier Type: -

Identifier Source: org_study_id