UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005627
Receipt number R000006649
Scientific Title Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes -prospective open-label controlled study-
Date of disclosure of the study information 2011/06/01
Last modified on 2013/12/07 13:30:33

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Basic information

Public title

Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes
-prospective open-label controlled study-

Acronym

Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes

Scientific Title

Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes
-prospective open-label controlled study-

Scientific Title:Acronym

Effects of sitagliptin and vildagliptin on glucose fluctuations in patients with type 2 diabetes

Region

Japan


Condition

Condition

type 2 diabetes mellitus

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of switching from sitagliptin to vildagliptin on glucose fluctuations in patients with type 2 diabetes, and vice versa.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

To evaluate changes in MAGE; mean amplitude of glycemic excursions before and after switching from sitagliptin to vildagliptin, and vice versa

Key secondary outcomes

1) M-value
2) fasting plasma glucose, HbA1c, glycoalbumin
3) beta cell function
4) changes in body weight, Body Mass Index, abdominal girth, blood pressure
5) several biomarkers


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-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

vildagliptin

Interventions/Control_2

sitagliptin

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) patients with type 2 diabetes using sitagliptin (50mg, once daily) or vildagliptin(50mg, twice daily) for more than 3 months
2) HbA1c 5.8-7.9% (JDS), HbA1c 6.2-8.3%(NGSP)
3) written informed consent

Key exclusion criteria

1) patients who received insulin injection therapy
2) severe hepatic dysfunction, renal dysfunction, heart failure
3) history of anaphylaxis of Sitagliptin or Vildagliptin,
4) pregnancy and lactation
5) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideaki Miyoshi

Organization

Hokkaido University Hospital

Division name

Department of Medicine II

Zip code


Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Email

hmiyoshi@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Miyoshi

Organization

Hokkaido University Hospital

Division name

Department of Medicine II

Zip code


Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Homepage URL


Email

hmiyoshi@med.hokudai.ac.jp


Sponsor or person

Institute

Department of Medicine II,
Hokkaido University Hospital

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

北海道大学病院(北海道)、クラーク病院(北海道)、栗原内科(北海道)、沖医院(北海道)


Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 01 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

2011 Year 05 Month 12 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date

2013 Year 03 Month 31 Day

Date of closure to data entry

2013 Year 04 Month 30 Day

Date trial data considered complete

2013 Year 04 Month 30 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 05 Month 22 Day

Last modified on

2013 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006649


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name