UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010199 |
|---|---|
| Receipt number | R000011946 |
| Scientific Title | Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study - |
| Date of disclosure of the study information | 2013/03/31 |
| Last modified on | 2014/09/09 10:29:52 |
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Basic information
Public title
Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -
Acronym
Continuous glucose profiles with vildagliptin versus sitagliptin in combination with insulin.
Scientific Title
Comparison of vildagliptin versus sitagliptin in combination with insulin using continuous glucose monitoring -prospective, randomized, open-label study -
Scientific Title:Acronym
Continuous glucose profiles with vildagliptin versus sitagliptin in combination with insulin.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the continuous glucose profiles byincreasing dose of sitagliptin or switching from sitagliptin to vildagliptin in patients with type 2 diabetes treated with sitagliptin and insulin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
MAGE; mean amplitude of glycemic excursions
Key secondary outcomes
1) M-value 2) glucose area under the curve 3) fasting plasma glucose, HbA1c, glycoalbumin, 1.5AG 4) beta cell function 5) several biomarkers 6) body weight, Body Mass Index 7) blood pressure
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sitagliptin
Interventions/Control_2
vildagliptin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with type 2 diabetes using sitagliptin (50mg) and insulin for more than 3 months
2) HbA1c 6.2-8.4% (NGSP)
3) written informed consent
Key exclusion criteria
1) severe hepatic dysfunction, renal dysfunction, heart failure.
2) history of anaphylaxis of sitagliptin or vildagliptin.
3) pregnancy.
4) patients who are inadequate to enter this study due to the other reasons by physician's judgments.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
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
Homepage URL
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 31 | 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
| 2013 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 09 | Day |
Last modified on
| 2014 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011946
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
