UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of metformin dose up in Japanese patients with type 2 diabetes inadequately controlled by combination therapy with vildagliptin and low-dose metformin
Title of the study (Brief title)	Efficacy and safety of metformin dose up in Japanese patients with type 2 diabetes treated with with vildagliptin (Build Up Study)
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare reduction of HbA1c from baseline between metformin dose up group and non-dose up group in vildagliptin-based therapy and investigate safety and tolerability of high dose of metformin in vildagliptin- based therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes of HbA1c from baseline
Key secondary outcomes	1)Target achievement rate of HbA1c (<6.0%) 2)Changes of insulin, glucagon, C-peptide, proinsulin/insulin rate, DPP-4 activity 3)Symptomatic hypoglycemic events and gastrointestinal disorders 4)inflammatory cytokines and lipid levels

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	metformin dose up is done targeting HbA1c<6.0% and maximum dose is 2250mg/day
Interventions/Control_2	Standard treatment is continued. However, if control is above 7.0%, physicians can increase dose of metformin up tp 1000mg.
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	1) Japanese patients with T2DM whose HbA1c 6.5-7.5% (NGSP) even after treatment with combination therapy of vildagliptin (50mg twice daily) and metformin (500-750mg/day) at least 3 months. 2) Over 20 and under 75 years old 3)male and female 4)3) written informed consent from each patient
Key exclusion criteria	1) history of lactic acidosis 2) renal dysfunction 3)under hemodialysis 4)serious liver disease with >100 IU/L in AST and/or ALT 5) Type 1 diabetes 6) under insulin treatment 7) under treatment for cancer 8) proliferative diabetic retinopathy 9)Excess consumption of alcohol 10) gastrointestinal disorders such as diarrhea and vomiting concern to dehydration 11) severe ketosis and diabetic coma or pre-coma 12)serious infective diseases, serious injury, pre- and per-operation 13) during pregnancy and lactation. 14) hypersensitivity of vildagliptin and metformin 15) high dose metformin treatment (>750mg/day)
Target sample size	60

Research contact person
Name of lead principal investigator	Akio Kanazawa
Organization	Juntendo university
Division name	Metabolism and Endocrinology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	akana@juntendo.ac.jp

Public contact
Name of contact person	Akio Kanazawa
Organization	Juntendo university
Division name	Metabolism and Endocrinology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	akana@juntendo.ac.jp

Sponsor
Institute	Juntendo university Department of Metabolism and Endocrinology
Institute
Department

Funding Source
Organization	Novartis Pharma
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 08 Day
Anticipated trial start date	2014 Year 02 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 12 Month 05 Day

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

Management information
Registered date	2014 Year 02 Month 08 Day
Last modified on	2016 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015282