Type 2 Diabets MellitusPhase 4NCT00369148
Combination of Glinides With Premixed Insulin
A Phase 4 study testing nateglinide(drug) mitiglinide(drug) in people with Type 2 Diabets Mellitus, run by Keio University at 6 sites in Japan.
Trial summary
Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabets Mellitus
- What is being tested?
- nateglinide(drug) mitiglinide(drug)
- How many people
- 60 participants
- Where
- 6 sitesJapan
- Study dates
- Jul 2004to Mar 2006
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetes
- Who undergoes twice daily injection of premixed insulin
- Whose HbA1c is more than 6.5% and less than 8.0%
Who cannot join
- Whose change of HbA1c is more than 1.0% during 12 weeks observational period
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Hamamatsu Red Cross Hospital
Hamamatsu, Shizuoka, 430-0907
Nippon Kokan Hospital
Kawasaki, Kanagawa, 210-0852
Saiseikai Central Hospital
Minato-ku, Tokyo, 108-0073
Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Tokyo Metropolitan Ohtsuka Hospital
Toshima-ku, Tokyo, 170-8476
About this study
Official title: Evaluation of Usefulness of Combination Therapy of Rapid Acting Insulin Secretagogue (Glinide) With Premixed Insulin in Type 2 Diabetes
Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.
Read the detailed description
Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.
- Conditions
- Type 2 Diabets Mellitus
- Being tested
- nateglinide(drug) mitiglinide(drug)
- Keywords
- glinides, premixed insulin, combination therapy, glycemic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nateglinide(drug) mitiglinide(drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
glycohemoglobin
Secondary outcomes (4)
anhydroglucitol
lipid profile
body weight
blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startJul 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabets MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Keio University
- Sponsor type
- University, hospital or other
- Investigators
- Akira Shimada, MD, PhD, Study chair, Keio UniversityYoshihito Atsumi, MD, Study director, Saiseikai Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369148
- Sponsor's protocol ID
- CS-NHK2
- Status last verified
- Aug 2009
- First submitted
- 28 Aug 2006
- Last updated
- 26 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Usefulness of Combination Therapy of Rapid Acting Insulin Secretagogue (Glinide) With Premixed Insulin in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00369148
- Acronym / sponsor ID
- CS-NHK2
- Conditions
- Type 2 Diabets Mellitus
- Keywords
- glinides, premixed insulin, combination therapy, glycemic control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Keio UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Study completion
- Mar 2006
- First posted
- 29 Aug 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.
Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.
Detailed description
Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of type 2 diabetes
- Who undergoes twice daily injection of premixed insulin
- Whose HbA1c is more than 6.5% and less than 8.0%
Key exclusion criteria (1 listed)
- Whose change of HbA1c is more than 1.0% during 12 weeks observational period
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 |
|---|---|---|
| nateglinide(drug) mitiglinide(drug) | Drug | – |
Primary outcome
glycohemoglobin
4 secondary outcomes
anhydroglucitol
lipid profile
body weight
blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2009.
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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.
Akira Shimada, MD, PhD study chair
Keio University
Yoshihito Atsumi, MD study director
Saiseikai Central Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nateglinide(drug) mitiglinide(drug) in people with Type 2 Diabets Mellitus, run by Keio University at 6 sites 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 1 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: finished, as of the sponsor's last update on 26 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycohemoglobin. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2009.