Unique ID issued by UMIN | UMIN000006199 |
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Receipt number | R000007330 |
Scientific Title | A Clinical trial of compound drugs for patients with type2 diabetes - Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. - |
Date of disclosure of the study information | 2011/09/01 |
Last modified on | 2013/09/27 09:29:20 |
A Clinical trial of compound drugs for patients with type2 diabetes
- Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -
A Clinical trial of compound drugs for patients with type2 diabetes
- Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -
A Clinical trial of compound drugs for patients with type2 diabetes
- Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -
A Clinical trial of compound drugs for patients with type2 diabetes
- Comparative analysis of the characteristics of postprandial hyperglycemia improving drugs for postprandial metabolic disorder. -
Japan |
type2 diabetes
Endocrinology and Metabolism |
Others
NO
Conduct a meal tolerance test by the test meal after single dose administration of voglibose 0.2mg, mitiglinide calcium hydrate 10mg, and glubes combination tablets for patients with type2 diabetes
Compare the change in blood glucose and lipid metabolic parameter, and the statistics of each group for studying improvement of postprandial metabolic disorder.
Safety,Efficacy
Efficacy endpoints: Measure the summary statistics of the measurement value and the changing value of the parameter (glucose, insulin, triglycerides, RLP-C, free fatty acids) after a meal tolerance test.
Measure the summary statistics of Emax, tmax and AUEC0-180.
Safety endpoints: The incidence of adverse events and side effect. For laboratory evidence, summary statistics are calculated.
Interventional
Cross-over
Randomized
Open -no one is blinded
Active
3
Treatment
Medicine |
Group A: control observation period (water,meal tolerance test)--washout--in stage 1 (BASEN,meal tolerance test)--washout--in stage 2(GLUBES,meal tolerance test)--washout--in stage 3 (GLUFAST,meal Tolerance Test)
Group B: control observation period (water,meal tolerance test)--washout--in stage 1(GLUFAST,meal tolerance test)--washout--in stage 2(BASEN,meal tolerance test)--washout--in stage 3(GLUBES,meal Tolerance Test)
Group C: control observation period (water,meal tolerance test)--washout--in stage 1(GLUBES,meal tolerance test)--washout--in stage 2(GLUFAST,meal tolerance test)--washout--in stage 3(BASEN,meal Tolerance Test)
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients treated only by a diabetes diets and exercise regimen or Patients who can have a washout period of glucositase inhibitor or glinide for more than 4weeks.
2) Patients who have been type2 diabetes blow 10 years.
3) Patients who is possible to ingest the test meal (a set of chicken cream, crackers and soft pudding).
4) Adult patients (>=20years) (at the time taking an agreement)
5) Outpatients
6) Patients who can voluntary agree to this study after being taken an explanation for significance and objectives of this study.
1) Patients having been treated by sulfonylureas within 3 months.
2) Patients treated by hyperlipidemia of fibrates.
3) Patients with a BMI of 40 or more.
4) Patients falling under the [contraindication] in attached files of the experimental drugs.
5) Patients falling under the [Special caution needed] in attached files of the experimental drugs and whom have high disability, and whom principal investigator concludes to be unsuitable for the test.
6) Patients whom principal investigator concludes to be unsuitable for the test, in other reasons.
12
1st name | |
Middle name | |
Last name | Masahiro Inoue |
Sasazuka inoue clinic
M.D
Sasazuka1-15-4,Shibuya-ku,Tokyo AKI Bildg.
03-3466-3348
erika-yamagishi@npo-acro.jp
1st name | |
Middle name | |
Last name | Erika Yamagishi |
NPO Advanced Clinical Research Organization
NPO Advanced Clinical Research Organization
4F Hoei Fuchu Bulding,2-10-3 Kotobukicho,Fuchu-shi,Tokyo
042-352-7676
erika-yamagishi@npo-acro.jp
Advanced Clinical Research Organization
Advanced Clinical Research Organization
Other
NO
2011 | Year | 09 | Month | 01 | Day |
Published
Completed
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 08 | Month | 19 | Day |
2013 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007330
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