UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013108 |
|---|---|
| Receipt number | 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 21:49:57 |
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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
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
akana@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university Department of Metabolism and Endocrinology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015282
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