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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013108
Receipt No. R000015282
Scientific Title 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
Date of disclosure of the study information 2014/02/08
Last modified on 2016/11/10

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Basic information
Public title 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
Acronym Efficacy and safety of metformin dose up in Japanese patients with type 2 diabetes treated with with vildagliptin (Build Up Study)
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Akio Kanazawa
Organization Juntendo university
Division name Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email akana@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akio Kanazawa
Organization Juntendo university
Division name Metabolism and Endocrinology
Zip code
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)

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
2014 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2014 Year 02 Month 08 Day
Date of IRB
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

Other
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

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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