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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002461
Receipt No. 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

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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 &#8805;106 &micro;mol/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
Email

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
Email knakano@yamashiro-hp.jp

Sponsor
Institute Yamashiro Public Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003013

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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