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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000031837 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | type 2 diabetes | |
Classification by specialty |
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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
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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)]
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | General Inuyama Chuo Hospital |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036358 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |