UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005266 |
|---|---|
| Receipt number | R000006262 |
| Scientific Title | Effects of thiazolidinedione and biguanide in groups divided according to diabetic pathophysiology |
| Date of disclosure of the study information | 2011/03/22 |
| Last modified on | 2016/09/19 09:37:22 |
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Basic information
Public title
Effects of thiazolidinedione and biguanide in groups divided according to diabetic pathophysiology
Acronym
Effects of thiazolidinedione and biguanide in groups divided according to diabetic pathophysiology
Scientific Title
Effects of thiazolidinedione and biguanide in groups divided according to diabetic pathophysiology
Scientific Title:Acronym
Effects of thiazolidinedione and biguanide in groups divided according to diabetic pathophysiology
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of thiazolidinedione and biguanide in groups divided according to diabetic pathophysiology prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
thiazolidinedione
Interventions/Control_2
biguanide
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
Type 2 diabetic patients who had been admitted to Osaka University Hospital and were treated by diet alone or diet plus insulin for at least 2 weeks, until fasting plasma glucose (FPG) was below 7.0 mmol/l, and then insulin resistance was evaluated by the insulin tolerance test and HOMA-IR
Key exclusion criteria
1. heart failure
2. severe liver and/or renal dysfunction
3. heavy drinkers, infectious disease, around operation, pregnancy
patients whom the doctor regarded as imapropriate for the subjects
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Iwahashi |
Organization
Graduate School of Medicine, Osaka University
Division name
Metabolic Medicine
Zip code
Address
2-2(B5) Yamadaoka Suita city
TEL
06-6879-3736
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Kozawa |
Organization
Graduate School of Medicine, Osaka University
Division name
Metabolic Medicine
Zip code
Address
TEL
Homepage URL
kjunji@imed2.med.Osaka-u.ac.jp
Sponsor or person
Institute
Department of Metablic Medicine, Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Osaka University
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 03 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 17 | Day |
Last modified on
| 2016 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006262
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
