UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief title)	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
Condition	type 2 diabetes mellitus
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Tatsuya Atsumi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Email	at3tat@med.hokudai.ac.jp

Public contact
Name of contact person	Hideaki Miyoshi
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Internal Medicine II
Address	Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-5915
Homepage URL
Email	hmiyoshi@med.hokudai.ac.jp

Sponsor
Institute	Study group for the treatment of type 2 diabetes in Sapporo
Institute
Department

Funding Source
Organization	The Japan Diabetes 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)

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）、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）

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 28 Day
Last modified on	2017 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012865