Type 2 Diabetes MellitusPhase 3NCT00213122
Effects of Miglitol on Daily Plasma Glucose in type2 Diabetes Treated With Insulin
A Phase 3 study testing miglitol in people with Type 2 Diabetes Mellitus, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
Trial summary
In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2 diabetic patients treated with insulin. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- miglitol
- How many people
- Not given
- Where
- 1 siteJapan
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type2 diabetes
- postprandial plasma glucose levels ≧180mg/dl
Who cannot join
- type1 diabetes
- AST(GOT) or ALT(GPT) ≧100IU/l
- creatinine ≧2.0mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2 diabetic patients treated with 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Promotiom Group, Study director, Sanwa Kagaku Kenkyusho Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213122
- Sponsor's protocol ID
- MG1007
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 28 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Miglitol on Daily Plasma Glucose in type2 Diabetes Treated With Insulin
- ClinicalTrials.gov ID
- NCT00213122
- Acronym / sponsor ID
- MG1007
- 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.
In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2 diabetic patients treated with insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type2 diabetes
- postprandial plasma glucose levels ≧180mg/dl
Key exclusion criteria (3 listed)
- type1 diabetes
- AST(GOT) or ALT(GPT) ≧100IU/l
- creatinine ≧2.0mg/dl
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 28 Sep 2006.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 Promotiom Group study director
Sanwa Kagaku Kenkyusho Co., Ltd.
1 site 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 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 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 28 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.
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 28 Sep 2006.