UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005813
Receipt number R000006873
Scientific Title Comparison of vildagliptin and alogliptin in patient with type 2 diabetes
Date of disclosure of the study information 2011/06/20
Last modified on 2017/06/26 12:23:06

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Basic information

Public title

Comparison of vildagliptin and alogliptin in patient with type 2 diabetes

Acronym

Comparison of vildagliptin and alogliptin

Scientific Title

Comparison of vildagliptin and alogliptin in patient with type 2 diabetes

Scientific Title:Acronym

Comparison of vildagliptin and alogliptin

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 purpose of this study is to compare the effect of vildagliptin and alogliptin swithed from sitagliptin on glycemic control in patients with type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Achievement rate of HbA1c <6.6%

Key secondary outcomes

1) Achievement rate of blood glucose <130mg/dl
2) Achievement rate of HbA1c <6.5% by sitagliptin treatment
3)Durability of vildagliptin or alogliptin


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

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Vildagliptin 100mg/day for 3 months

Interventions/Control_2

alogliptin 20mg/day for 3 monts

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1)Outpatients who have been taking 50mg of sitagliptin for 1month or monre
2)3)Type 2 diabete mellitus (HbA1c level:more than 6.6%, less than 9.1%
4)Pts with written IC
5)Age more than 20, less than 85

Key exclusion criteria

1)severe ketosis, diabetic coma within 6 months
2)severe infection, before operation, severe trauma
3)severe hepatic dysfunction
4) severe renal dysfunction (sCr: more than 1.5mg/dl)
5)Patients who use of insulin
6)regnacy
7)Allergy for vildagliptin or alogliptin
8)Patients judged by the investigator to be ineligible for some other reason

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadashi Yamakawa

Organization

Yokohama City University Medical Center

Division name

Department of Endocrinology and Diabetes

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

yamakat@urahp.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Erina Shigematu

Organization

Yokohama City University Medical Center

Division name

Department of Endocrinology and Diabetes

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL


Email

erina-sgmt@live.jp


Sponsor or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

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

横浜市立大学附属市民総合医療センター(神奈川県)


Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 07 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 06 Month 20 Day

Last modified on

2017 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name