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Jikei Optimal Insulin Therapy in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Jikei University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novo Nordisk
Information provided by:
Jikei University School of Medicine
ClinicalTrials.gov Identifier:
NCT00348231
First received: July 3, 2006
Last updated: August 31, 2006
Last verified: June 2006
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
 Drug: dual-action insulin analog

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jikei University School of Medicine:

Primary Outcome Measures:
  • HbA1c
  • daily profile of blood glucose

Secondary Outcome Measures:
  • IMT
  • QOL

Estimated Enrollment: 60
Study Start Date: November 2004
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348231

Contacts
Contact: Yumi Miyashita, MD +081334331111 ext 3249 yumi-m@jikei.ac.jp

Locations
Japan
The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicine Recruiting
Tokyo, Japan, 1058461
Contact: Yumi Miyawshita, MD     +081334331111 ext 3249     yumi-m@jikei.ac.jp    
Sponsors and Collaborators
Jikei University School of Medicine
Novo Nordisk
Investigators
Principal Investigator: Yumi Miyashita, MD The Jikei university school of medicine
  More Information

No publications provided by Jikei University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00348231     History of Changes
Other Study ID Numbers: 15-195(4220)
Study First Received: July 3, 2006
Last Updated: August 31, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Jikei University School of Medicine:
diabetes mellitus, biphasic insulin analogue

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013