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Jikei Optimal Insulin Therapy in Type 2 Diabetes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00348231
Enrollment
60
Registered
2006-07-04
Start date
2004-11-30
Completion date
2006-08-31
Last updated
2006-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, biphasic insulin analogue

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.

Interventions

DRUGdual-action insulin analog

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
Jikei University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
HbA1c
daily profile of blood glucose

Secondary

MeasureTime frame
IMT
QOL

Countries

Japan

Contacts

Primary ContactYumi Miyashita, MD
yumi-m@jikei.ac.jp+081334331111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026