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 &#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 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


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

Value
https://center6.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