Diabetes Mellitus, Type 2NCT00348231
Jikei Optimal Insulin Therapy in Type 2 Diabetes
A study testing dual-action insulin analog in people with Diabetes Mellitus, Type 2, run by Jikei University School of Medicine at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- dual-action insulin analog
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2004to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Type 2 diabetes
- secondary failure of SU drug
- whose age is to 80 from 20 years old
Who cannot join
- who has the complication
- who has a allergy of insulin
- who is pregnant
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
The Jikei university school of medicine division of diabetes and endoclinology dept. of internal medicine
Tokyo, Tokyo, 1058461
Yumi Miyawshita, MD, +081334331111 ext. 3249, yumi-m@jikei.ac.jp
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- dual-action insulin analog
- Keywords
- diabetes mellitus, biphasic insulin analogue
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual-action insulin analogDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
daily profile of blood glucose
Secondary outcomes (2)
IMT
QOL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startNov 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Jikei University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Investigators
- Yumi Miyashita, MD, Principal investigator, The Jikei University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348231
- Sponsor's protocol ID
- 15-195(4220)
- Status last verified
- Jun 2006
- First submitted
- 3 Jul 2006
- Last updated
- 1 Sep 2006
- Results posted
- No
Publications
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.
PubMed 18507868
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jikei Optimal Insulin Therapy in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00348231
- Acronym / sponsor ID
- 15-195(4220)
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes mellitus, biphasic insulin analogue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Jikei University School of MedicineUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Nov 2004
- Study completion
- Aug 2006
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Type 2 diabetes
- secondary failure of SU drug
- whose age is to 80 from 20 years old
Key exclusion criteria (3 listed)
- who has the complication
- who has a allergy of insulin
- who is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual-action insulin analog | Drug | – |
Primary outcome
HbA1c
daily profile of blood glucose
2 secondary outcomes
IMT
QOL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2006.
- Derived from this study: PubMed 18507868Miyashita 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yumi Miyashita, MD principal investigator
The Jikei University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual-action insulin analog in people with Diabetes Mellitus, Type 2, run by Jikei University School of Medicine at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yumi Miyashita, MD (+081334331111 ext. 3249, yumi-m@jikei.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00348231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2006.