Unique ID issued by UMIN | UMIN000007203 |
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Receipt number | R000008392 |
Scientific Title | A clinical study of combination drug against type 2 diabetes - Glubes combination tablets for patients poorly controlled with a-GI or Glinide - |
Date of disclosure of the study information | 2012/02/03 |
Last modified on | 2013/09/27 09:30:05 |
A clinical study of combination drug against type 2 diabetes
- Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
A clinical study of combination drug against type 2 diabetes
- Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
A clinical study of combination drug against type 2 diabetes
- Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
A clinical study of combination drug against type 2 diabetes
- Glubes combination tablets for patients poorly controlled with a-GI or Glinide -
Japan |
type2 diabetes
Endocrinology and Metabolism |
Others
NO
Study the efficacy and safety of taking unblindedly Glubes combination tablets, combined with mitiglinide calcium hydrate and voglibose, for type 2 diabetes patients who had been taking inadequate glycemic control with a monotherapy of a-GI(voglibose, acarbose, or miglitol) or glinide(mitiglinide calcium hydrate, nateglinide) in addition to diet and exercise regimen.
Safety,Efficacy
Efficacy endpoints:HbA1c(the JDS), blood glucose, glycated albumin, insulin, 1.5-AG, C-peptide, free fatty acids, triglycerides, apoB48, and apoC-3. Calculate HOMA-IR and HOMA-B in order to evaluate insulin resistance and function of pancreatic beta cell at each evaluation point.
Primary endpoints:HbA1c(the JDS) at the final evaluation point of each patient.
Compare the items of efficacy endpoints and the descriptive statistical number of the changing rate at each evaluation points, to the rate at 0week with t-test.
Calculate the 6.5% achievement ratio of HbA1c at each evaluation points.
Study the efficacy of taking a-GI or each glinide drugs which had been used before this study.
Safety endpoints:Evaluate the frequency and the occurrence of adverse events during this study.
Calculate the number of events and cases on the treatments of every 4 weeks, and calculate the total number of events and cases.
Analyze the adverse events against the drug by its grade, organ, and causal relationship.
Measure the descriptive statistics of observation period(0week) and treatment period(16th week) as laboratory evidences, and find the ratio of appearance of unusual change on each test values.
Measure the transitions of values of weights and blood pressures, on every 4 weeks of treatment periods.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Treatment
Medicine |
0th week: Perform examination under fasting conditions at the clinic. Perform examination again after the patients, who have signed a consent form, take an agent of a-GI or Glinide, and take a meal tolerance test
16th week: Perform examination under fasting conditions at the clinic. Perform examination again after the patients, who have signed a consent form, take the Glubes combination tablets and take a meal tolerance test
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients poorly controlled with the monotherapy of a-GI or glinide in addition to diet and exercise regimen, and regarded as appropriate to be treated with Glubes combination tablets.
2) Patients who have 6.5% HbA1c or more.
3) Age 20<=
4) Outpatient
5) Patients who voluntarily signed to the consent form with the explanation of the significance and the objectives of this study.
1) Patients who are applicable to the [taboo issue] in a package insert of Glubes combination tablets.
Patients who have severe ketosis, precoma or diabetic coma or type 1 diabetes.
Patients with severe infection or severe injury.
Patients accepting surgery.
Patients with a history of hypersensitivity to any component of this drug.
Pregnant women and women suspected to be pregnant.
2) Patients whom the principal investigator and investigators decided not to be appropriate for taking Glubes combination tablets, on the point of [Special caution needed] and [side effects] in the package insert.
30
1st name | |
Middle name | |
Last name | Yoshihiko Sato |
Sato Internal medicine clinic
M.D
Nanpeidaichou13-1,Shibuya-ku,Tokyo Sato Bilding1F
042-352-7676
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
2012 | Year | 02 | Month | 03 | Day |
Published
Completed
2012 | Year | 01 | Month | 12 | Day |
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 02 | Month | 02 | Day |
2013 | Year | 09 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008392
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