UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003951
Receipt number R000004758
Scientific Title Effect of a DPP-4 inhibitor or an alpha-glucosidase inhibitor on endothelial function in patients with type 2 diabetes
Date of disclosure of the study information 2010/10/01
Last modified on 2014/08/31 15:20:48

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Basic information

Public title

Effect of a DPP-4 inhibitor or an alpha-glucosidase inhibitor on endothelial function in patients with type 2 diabetes

Acronym

Effect of a DPP-4 inhibitor on endothelial function (EDGE)

Scientific Title

Effect of a DPP-4 inhibitor or an alpha-glucosidase inhibitor on endothelial function in patients with type 2 diabetes

Scientific Title:Acronym

Effect of a DPP-4 inhibitor on endothelial function (EDGE)

Region

Japan


Condition

Condition

Type 2 diabetic patients

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effects of a DPP-4 inhibitor, sitagliptin, and an alpha-glucosidase inhibitor, voglibose, on endothelial function in patients with type 2 diabetes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

% FMD after 12 weeks

Key secondary outcomes

Change and % change in the following values in the 2 groups at 12 weeks after the initiation of treatment
FPG
HbA1c
Incretin concentration (GIP, GLP-1)
Endogenous insulin / glucagon
C-peptide
Lipid profile (TC, HDL-C, TG)
Adiponectin
CD34
hs-CRP
PTX-3
MDA-LDL
Urine-OHDG


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

DPP-4 inhibitor

Interventions/Control_2

alpha-glucosidase inhibitor

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, T2DM patients those who have been treated with the diabetic therapy and whose blood glucose has not been sufficiently controlled
2, Obtaining written informed consent

Key exclusion criteria

1, The patient under insulin treatment
2, The patient under alpha-GI or Gulinide treatment
3, Type 1 diabetes mellitus
4, Insufficiently controlled diabetes mellitus (HbA1c >= 9.0% )
5, Insufficiently controlled hypertension (SBP>=160mmHg)
6, Severe ketosis, diabetic coma, or precoma within the past six months
7, Severe infectious disease, pre/ post operation or serious injury
8, Women who are pregnant, possibly pregnant, or are breastfeeding
9, Mild renal dysfunction (sCr>=1.5 mg/dl)
10, Hypersensitivity or allergy to sitagliptin and voglibose
11, Patients who are determined by the investigators to be unsuitable

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Ito

Organization

Okayama University Medical School

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-5-1 Shikada-cho Kita-ku Okayama

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Cardiovascular Dysfunction Study group

Division name

Research Secretariat Office

Zip code


Address


TEL

03-3814-1616

Homepage URL


Email



Sponsor or person

Institute

Cardiovascular Dysfunction Study group

Institute

Department

Personal name



Funding Source

Organization

Osaka Prevention Institute for Cancer and Cardiovascular Diseases Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2010 Year 10 Month 01 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

2010 Year 07 Month 20 Day

Date of IRB


Anticipated trial start date

2010 Year 10 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

Nakamura K et al.: Cardiovascular Diabetology 2014, 13:110


Management information

Registered date

2010 Year 07 Month 26 Day

Last modified on

2014 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name