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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 A/S
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

July 3, 2006
August 31, 2006
November 2004
Not Provided
  • HbA1c
  • daily profile of blood glucose
Not Provided
Complete list of historical versions of study NCT00348231 on ClinicalTrials.gov Archive Site
  • IMT
  • QOL
Not Provided
Not Provided
Not Provided
 
Jikei Optimal Insulin Therapy in Type 2 Diabetes
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: dual-action insulin analog
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2006
Not Provided

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
Both
20 Years to 80 Years
No
Contact: Yumi Miyashita, MD +081334331111 ext 3249 yumi-m@jikei.ac.jp
Japan
 
NCT00348231
15-195(4220)
Not Provided
Not Provided
Jikei University School of Medicine
Novo Nordisk A/S
Principal Investigator: Yumi Miyashita, MD The Jikei university school of medicine
Jikei University School of Medicine
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP