UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002461 |
|---|---|
| Receipt number | R000003013 |
| Scientific Title | Effect of pioglitazone in combination with glimepiride therapy on various parameters of insulin resistance including lipoprotein subclass levels in patients with type 2 diabetes |
| Date of disclosure of the study information | 2009/09/10 |
| Last modified on | 2009/09/07 07:22:00 |
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Basic information
Public title
Effect of pioglitazone in combination with glimepiride therapy on various parameters of insulin resistance including lipoprotein subclass levels in patients with type 2 diabetes
Acronym
Effect of pioglitazone on insulin resistance parameters
Scientific Title
Effect of pioglitazone in combination with glimepiride therapy on various parameters of insulin resistance including lipoprotein subclass levels in patients with type 2 diabetes
Scientific Title:Acronym
Effect of pioglitazone on insulin resistance parameters
Region
| Japan |
Condition
Condition
Type II Diabeteis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To better understand the mechanism of the efficacy of pioglitazone as an insulin sensitizer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Indies of glucose control.
2) Various adipokines and inflammatory parameters.
3) Abdominal fat distribution by CT.
4) Lipoprotein subclass according to particle size.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pioglitazone + glimepiride
Interventions/Control_2
Metformin + glimepiride
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Newly diagnosed type 2 diabetes mellitus
Key exclusion criteria
(i) a serum creatinine concentration ≥106 µmol/l; (ii) chronic liver disease or a clinical history and/or signs of cardiovascular, cerebrovascular or peripheral arterial disease; (iii) heavy smoking or drinking; and (iv) use of thiazolidinediones, biguanides and/or insulin in the 3 months preceding the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Nakano |
Organization
Yamashiro Public Hospital
Division name
Internal Medicine
Zip code
Address
74-1 Kowaza-ikeda, Owaza-kizu, Kizugawa-shi, Kyoto-fu
TEL
0774-72-0235
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Nakano |
Organization
Yamashiro Public Hospital
Division name
Internal Medicine
Zip code
Address
74-1 Kowaza-ikeda, Owaza-kizu, Kizugawa-shi, Kyoto-fu
TEL
0774-72-0235
Homepage URL
knakano@yamashiro-hp.jp
Sponsor or person
Institute
Yamashiro Public Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamashiro Public Hospital
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
公立山城病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 07 | Day |
Last modified on
| 2009 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003013
