- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00348231
Jikei Optimal Insulin Therapy in Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yumi Miyashita, MD
- Phone Number: 3249 +081334331111
- Email: yumi-m@jikei.ac.jp
Study Locations
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-
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Tokyo, Japan, 1058461
- Recruiting
- The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicine
-
Contact:
- Yumi Miyawshita, MD
- Phone Number: 3249 +081334331111
- Email: yumi-m@jikei.ac.jp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
HbA1c
|
daily profile of blood glucose
|
Secondary Outcome Measures
Outcome Measure |
---|
IMT
|
QOL
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yumi Miyashita, MD, The Jikei University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-195(4220)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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