UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000733 |
|---|---|
| Receipt number | R000000881 |
| Scientific Title | Comparison of the effects on BS control, plasma lipid and atherogenesis among pioglitazone and metformin in Japanese type 2 diabetic patients |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2007/12/28 15:08:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of the effects on BS control, plasma lipid and atherogenesis among pioglitazone and metformin in Japanese type 2 diabetic patients
Acronym
Differential effect on arterial stiffness among pioglitazone and metformin in type 2 diabetes mellitus
Scientific Title
Comparison of the effects on BS control, plasma lipid and atherogenesis among pioglitazone and metformin in Japanese type 2 diabetic patients
Scientific Title:Acronym
Differential effect on arterial stiffness among pioglitazone and metformin in type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinically admitted doses of pioglitazine and metformin in Japan are different from those in Western countries, and no clinical trial has been performed in Japan to investigate the differential effects on blood sugar, plasma lipid, markers of oxidative stress and arterial stiffness among pioglitazone and metformin utilizing clinically admitted doses. We aim to clarify these effects utilizing cross-over design.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c, PWV, urinary 8-OHdG, PAF acetylhydrolase
Key secondary outcomes
FBS, insulin, total cholesterol, HDL-C,
triglycerides, LDL-C, hsCRP, urinary F2-isoprostanes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of pioglitazone In the first 3 months followed by the administration of metformin for three months.
Interventions/Control_2
Administration of metformin In the first 3 months followed by the administration of pioglitazone for three months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who had been treated with diet therapy, exercise therapy, and/or sulfonylurea for more than 3 months.
2) The level of HbA1c:
If not administered with pioglitazone or metformin, 6.5% to 8.4%. If administered with pioglitazone or metformin, 6.0% to 7.9%, and after cessation of pioglitazone or metformin, 6.5% to 8.4%
3) The change in HbA1c level is less than 10% in the last 3 months.
4) SBP less than 140 mmHg.
5) Cigarettes smoking less than 20 per day.
6) no criteria in BMI level.
7) patients followed in outpatient department.
8) Who can understand the protocol and have the ability to agree with this study.
Key exclusion criteria
1) type 1 diabettes patient
2) patient on insulin treatment
3) Diabetic ketoasidosis, diabetic coma or pre-coma
4) Who takes probucol
5) Who takes supplements containing vitamin C or Vitamin E
6) Severe liver dysfunction
7) Who has a history of adverse effect with pioglitazone
8) renal failure (plasma creatinine more than 1.2 mg/dl, daily urine protein more than 1.0g)
9) heart failure
10) history of heart failure and miocardial infarction within 6 months. Who has a abnormal ECG finding.
11) history of cerebrovascular disease.
12) Who needs insulin administration for clinical condition.
13) Who has a history of hypersensitivity against pioglitazone or metformin.
14) Cases which meet the criteria for prohibition of metformin administration
15) patient who is pregnant of brest-feeding. patient who has a possibility of pregnancy.
16) Who suffers from malignant disease.
17) addiction to alcohol or drug
18) Who are enrolled in the other clinical trials.
19) Who is judged by the investigators to be inappropiriate for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Tsukamoto |
Organization
Depatment of Metabolic Diseases, Graduate School of Medicine
Division name
University of Tokyo
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo
Division name
Clinical Research Center
Zip code
Address
7-3-1, Hongou, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Metabolic Diseases, Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2003 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 06 | Month | 05 | Day |
Last modified on
| 2007 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000881
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
