Jikei Optimal Insulin Therapy in Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
dual-action insulin analog
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes mellitus, biphasic insulin analogue
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
Sites / Locations
- The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicineRecruiting
Outcomes
Primary Outcome Measures
HbA1c
daily profile of blood glucose
Secondary Outcome Measures
IMT
QOL
Full Information
NCT ID
NCT00348231
First Posted
July 3, 2006
Last Updated
August 31, 2006
Sponsor
Jikei University School of Medicine
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT00348231
Brief Title
Jikei Optimal Insulin Therapy in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Jikei University School of Medicine
Collaborators
Novo Nordisk A/S
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes mellitus, biphasic insulin analogue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dual-action insulin analog
Primary Outcome Measure Information:
Title
HbA1c
Title
daily profile of blood glucose
Secondary Outcome Measure Information:
Title
IMT
Title
QOL
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yumi Miyashita, MD
Phone
+081334331111
Ext
3249
Email
yumi-m@jikei.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yumi Miyashita, MD
Organizational Affiliation
The Jikei University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicine
City
Tokyo
ZIP/Postal Code
1058461
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumi Miyawshita, MD
Phone
+081334331111
Ext
3249
Email
yumi-m@jikei.ac.jp
12. IPD Sharing Statement
Citations:
PubMed Identifier
18507868
Citation
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.
Results Reference
derived
Learn more about this trial
Jikei Optimal Insulin Therapy in Type 2 Diabetes
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