UMIN-CTR Clinical Trial

Public title

Study for the effects of vildagriptin in combination with metformin on vascular endothelial function and systemic metabolism in patients with type 2 diabetes -multicenter, prospective, randomized, open-label, parallel group comparison-

Acronym

Study for the effects of vildagriptin in combination with metformin on vascular endothelial function and systemic metabolism in type 2 DM patients

Scientific Title

Study for the effects of vildagriptin in combination with metformin on vascular endothelial function and systemic metabolism in patients with type 2 diabetes -multicenter, prospective, randomized, open-label, parallel group comparison-

Scientific Title:Acronym

Study for the effects of vildagriptin in combination with metformin on vascular endothelial function and systemic metabolism in type 2 DM patients

Region

Japan

Condition

type 2 diabetes mellitus

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects of vildagriptin in combination with metformin on vascular endothelial function as compared with high dose metformin in patients with type 2 diabetes

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV

Primary outcomes

Change in FMD (Flow Mediated Dilatation) between the treatment groups

Key secondary outcomes

1) Change in Endo-PAT between the treatment groups, 2) change in FMD within each group, 3) correlation between FMD and HbA1c, 4) change between the treatment groups and within each groups in blood sugar tests such as HbA1c, FPG 1,5AG and GA, beta cell function, TBI (Toe-brachial index) , Task force monitor, laboratory tests and biomarkers, 4) safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

vildagliptin

Interventions/Control_2

metformin

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

Outpatients with type 2 diabetes who meet following criteria:
1) age: 20 - 75 years old, 2) HbA1c: 7.0-8.5%, 3) administrating 500-750mg of metformin more than 4 weeks, 4) well-controlled in terms of blood pressure and lipids, 5) made a written informed consent

Key exclusion criteria

1) patients who receive insulin injection therapy, 2) severe respiratory disease, renal dysfunction and heart disease, 3) moderate or severe renal dysfunction (1.3 and 1.2 mg/dL or more for male and female, respectively), 4) hepatitis or hepatocirrhosis (AST/GOT or ALT/GPT: 100U or more), 5) malignant tumor, 6) history of angina, myocardial infarction, stroke or arteriosclerotic diseases, 7) patients who receive thiazolidinediones, alpha-glucosidase inhibitor, GLP-1 receptor agonist or DPP-4 inhibitor in 8 weeks, 8) hypersensitivity to study drugs on this study, 9) pregnancy, nursing woman or possibly pregnant woman, 10) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuya Atsumi

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

at3tat@med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Hideaki Miyoshi

Organization

Graduate School of Medicine, Hokkaido University

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

Institute

Study group for the treatment of type 2 diabetes in Sapporo

Institute

Department

Personal name

Organization

The Japan Diabetes Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院（北海道）、青木内科クリニック（北海道）、大塚眼科病院（北海道）、大通り内科クリニック（北海道）、小笠原クリニック札幌病院（北海道）、小野百合内科クリニック（北海道）、クラーク病院（北海道）、栗原内科（北海道）、国立病院機構北海道医療センター（北海道）、札幌社会保険総合病院（北海道）、市立札幌病院（北海道）、時計台病院（北海道）、 斗南病院（北海道）、北海道社会保険病院（北海道）、萬田記念病院（北海道）、NTT東日本札幌病院（北海道）

Date of disclosure of the study information

2013

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

20

Day

Date of IRB

Anticipated trial start date

2013

Year

07

Month

01

Day

Last follow-up date

2016

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

06

Month

28

Day

Last modified on

2017

Year

01

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012865