UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010199
Receipt number R000011946
Scientific Title Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -
Date of disclosure of the study information 2013/03/31
Last modified on 2014/09/09 10:29:52

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Basic information

Public title

Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -

Acronym

Continuous glucose profiles with vildagliptin versus sitagliptin in combination with insulin.

Scientific Title

Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -

Scientific Title:Acronym

Continuous glucose profiles with vildagliptin versus sitagliptin in combination with insulin.

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 compare the continuous glucose profiles byincreasing dose of sitagliptin or switching from sitagliptin to vildagliptin in patients with type 2 diabetes treated with sitagliptin and insulin.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

MAGE; mean amplitude of glycemic excursions

Key secondary outcomes

1) M-value 2) glucose area under the curve 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure


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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

sitagliptin

Interventions/Control_2

vildagliptin

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) and insulin for more than 3 months
2) HbA1c 6.2-8.4% (NGSP)
3) written informed consent

Key exclusion criteria

1) severe hepatic dysfunction, renal dysfunction, heart failure.
2) history of anaphylaxis of sitagliptin or vildagliptin.
3) pregnancy.
4) patients who are inadequate to enter this study due to the other reasons by physician's judgments.

Target sample size

34


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideaki Miyoshi

Organization

Hokkaido University Hospital

Division name

Department of Internal Medicine II

Zip code


Address

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

TEL

011-706-5915

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Miyoshi

Organization

Hokkaido University Hospital

Division name

Department of Internal 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

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

None

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)


Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 31 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

2013 Year 03 Month 07 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 31 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 03 Month 09 Day

Last modified on

2014 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011946


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name