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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual-action insulin analog | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | ||
| daily profile of blood glucose |
| Measure | Description | Time Frame |
|---|---|---|
| IMT | ||
| QOL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yumi Miyashita, MD | Contact | +081334331111 | 3249 | yumi-m@jikei.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yumi Miyashita, MD | The Jikei University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicine | Recruiting | Tokyo | Tokyo | 1058461 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18507868 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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