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
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
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
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
