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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003951
Receipt No. 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

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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
Institute Cardiovascular Dysfunction Study group
Institute
Department

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
URL(English) https://upload.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


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