Type 2 Diabetes MellitusPhase 3NCT00213070
Double-Blind Trial of Miglitol in Type 2 Diabetic Patients With Insulin Treatment
A Phase 3 study testing Miglitol in people with Type 2 Diabetes Mellitus, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 16 sites in Japan.
Trial summary
The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus with treated insulin. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Miglitol
- How many people
- Not given
- Where
- 16 sitesJapan
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type2 diabetes
- Criteria of postprandial plasma glucose and HbA1c are met
Who cannot join
- Type1 diabetes
- Patients with antidiabetic drugs
- The other exclusion criteria are met
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
Study site
Aichi
Study site
Chiba
Study site
Fukuoka
Study site
Gifu
Study site
Gunma
Study site
Hokkaido
Study site
Ibaraki
Study site
Kagoshima
Study site
Kanagawa
Study site
Kumamoto
Study site
Miyazaki
Study site
Ōita
Study site
Okinawa
Study site
Saitama
Study site
Shiga
Study site
Tokyo
About this study
The purpose of this study is evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus with treated insulin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Miglitol
- Keywords
- alpha-glucosidase inhibitor,Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiglitolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Promotion Group, Study director, Sanwa Kagaku Kenkyusho Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213070
- Sponsor's protocol ID
- MG1005
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Trial of Miglitol in Type 2 Diabetic Patients With Insulin Treatment
- ClinicalTrials.gov ID
- NCT00213070
- Acronym / sponsor ID
- MG1005
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- alpha-glucosidase inhibitor,Insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 21 Sep 2005 (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 evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus with treated insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type2 diabetes
- Criteria of postprandial plasma glucose and HbA1c are met
Key exclusion criteria (3 listed)
- Type1 diabetes
- Patients with antidiabetic drugs
- The other exclusion criteria are met
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 |
|---|---|---|
| Miglitol | Drug | – |
Primary outcome
Not reported in the source record.
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 21 Sep 2006.
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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.
Clinical Promotion Group study director
Sanwa Kagaku Kenkyusho Co., Ltd.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Miglitol in people with Type 2 Diabetes Mellitus, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 16 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 2 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: finished, as of the sponsor's last update on 21 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 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 21 Sep 2006.