UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031837 |
|---|---|
| Receipt number | R000036358 |
| Scientific Title | Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin: randomised crossover study |
| Date of disclosure of the study information | 2018/03/22 |
| Last modified on | 2018/09/21 09:04:21 |
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Basic information
Public title
Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin: randomised crossover study
Acronym
Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin
Scientific Title
Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin: randomised crossover study
Scientific Title:Acronym
Early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate an early combination efficacy of vildagliptin (DPP-4 inhibitor) in basal-bolus insulin therapy with metformin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
15% reduction achieving number of days [mean glucose level (24:00)]
Key secondary outcomes
15% reduction achieving time (hour) [mean glucose level (0:00-8:00, every 1 hour)]
15% reduction achieving number of days [mean glucose level (0:00-8:00)]
15% reduction achieving number of days [mean glucose level (8:00-24:00)]
15% reduction achieving number of days [SD (0:00-8:00)]
15% reduction achieving number of days [SD (24:00)]
15% reduction achieving number of days [SD (8:00-24:00)]
Glycemic variability percentage (GVP) from the day before intervention start to 15% reduction achieving
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
FreeStyle Libre Pro is attached after admission. Vildagliptin 100 mg are started to use from day3 and dose of metformin increases (500 to 1000 mg) from day5. Then, vildagliptin is washed out and metformin is reduced (1000 to 500 mg). Then, dose of metformin increases (500 to 1000 mg) from day10 and vildagliptin 100 mg are started to use from day12.
Interventions/Control_2
FreeStyle Libre Pro is attached after admission. dose of metformin increases (500 to 1000 mg) from day3 and vildagliptin 100 mg are started to use from day5. Then, vildagliptin is washed out and metformin is reduced (1000 to 500 mg). Then, vildagliptin 100 mg are started to use from day10 and dose of metformin increases (500 to 1000 mg) from day12.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic patients medicated metformin 500 mg + basal-bolus insulin therapy of Glargine300+glulisine for 3 month or longer
Key exclusion criteria
renal dysfunction (patients whose estimated glomerular filtration rate was less than 45 ml/min/1.73m2)
judged to be unsuitable for participation for medical reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
General Inuyama Chuo Hospital
Division name
Diabetes
Zip code
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL
0568-62-8111
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
General Inuyama Chuo Hospital
Division name
Diabetes
Zip code
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL
0568-62-8111
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
General Inuyama Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 03 | Month | 22 | 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
| 2018 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 22 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036358
