UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010871
Receipt number R000012200
Scientific Title The effects of sitagliptin on albuminuria in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2013/06/04
Last modified on 2014/01/04 20:21:29

* 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

The effects of sitagliptin on albuminuria in patients with type 2 diabetes mellitus

Acronym

effects of sitagliptin on albuminuria

Scientific Title

The effects of sitagliptin on albuminuria in patients with type 2 diabetes mellitus

Scientific Title:Acronym

effects of sitagliptin on albuminuria

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 aim of this study was to determine the effect of sitagliptin on microalbuminuria in patients with type 2 diabetes mellitus

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome was changes in urinary albumin excretion at 6 months.

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

sitagliptin 50 mg

Interventions/Control_2

other oral glucose-lowering agents

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

The study subjects were patients with type 2 diabetes mellitus whose hemoglobin A1c (HbA1c) was lower than 8.4% (according to the National Glycohaemoglobin Standardisation Programme [NGSP]) despite treatment with pioglitazone (15-30 mg/day) for at least 6 months, aged <80 years, who received treatment at the Outpatient Department of the University of Occupational and Environmental Health Hospital or its affiliated hospitals.

Key exclusion criteria

Patients with a history of ketoacidosis, patients with type 1 diabetes, patients with nephropathy (serum creatinine: males >1.5 mg/dL females >1.3 mg/dL), patients treated with insulin, and women who were possibly pregnant were excluded from the study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yosuke Okada

Organization

School of Medicine, University of Occupational and Environmental Health

Division name

First Department of Internal Medicine

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku Kitakyushu

TEL

093-603-1611

Email

y-okada@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroko Mori

Organization

University of Occupational and Environmental Health

Division name

First Department of Internal Medicine

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku Kitakyushu

TEL

093-603-1611

Homepage URL


Email

hiroko.mori.0624@gmail.com


Sponsor or person

Institute

University of Occupational and Environmental Health

Institute

Department

Personal name



Funding Source

Organization

First Department of Internal Medicine, University of Occupational and Environmental Health

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



Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 04 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

2012 Year 02 Month 20 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 20 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

2013 Year 06 Month 04 Day

Last modified on

2014 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012200


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name