UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006217 |
|---|---|
| Receipt number | R000007360 |
| Scientific Title | Difference in effect on post-meal lipid, proinsulin, GIP and GLP-1 between Sitagliptin, Vildagliptin and Alogliptin in T2DM using DPP-4 inhibitor |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2023/05/30 13:55:13 |
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Basic information
Public title
Difference in effect on post-meal lipid, proinsulin, GIP and GLP-1 between Sitagliptin, Vildagliptin and Alogliptin in T2DM using DPP-4 inhibitor
Acronym
Clinical study of DPP-4 inhibitor therapy on post meal lipid, proinsulin, GIP and GLP-1
Scientific Title
Difference in effect on post-meal lipid, proinsulin, GIP and GLP-1 between Sitagliptin, Vildagliptin and Alogliptin in T2DM using DPP-4 inhibitor
Scientific Title:Acronym
Clinical study of DPP-4 inhibitor therapy on post meal lipid, proinsulin, GIP and GLP-1
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of Sitagliptin,Vildagliptin and Alogliptin on metabolic control in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lipid profile(pre-and post-meal(30min,1,2,3hours)triglyceride, pre- and post-meal(30min,1,2,3hours)chylomicron, pre- and post-meal(30min,1,2,3hours)VLDL, pre- and post-meal(30min,1,2,3hours)IDL, pre- and post-meal(30min,1,2,3hours)native LDL, pre- and post-meal(30min,1,2,3hours)small dense LDL, pre- and post-meal(30min,1,2,3hours)HDL
Key secondary outcomes
HbA1c, pre- and post-meal blood glucose(30min,1,2,3hours), pre-and post-meal(30min,1,2,3hours)insulin, pre- and post-meal(30min,1,2,3hours)proinsulin, pre- and post-meal(30min,1,2,3hours)C-peptide , pre- and post-meal(30min,1,2,3hours)GLP-1, pre- and post-meal(30min,1,2,3hours)GIP, pre- and post-meal(30min,1,2,3hours)glucagon
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sitagliptin 50mg/day for 3 month
Interventions/Control_2
Vildagliptin 100mg/day for 3 month
Interventions/Control_3
Alogliptin 25mg/day for 3 month
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)Type 2 Diabetes Mellitus (HbA1c level: more than 6.5%, less tess than 10.0%)
2)Patients with written IC
Key exclusion criteria
1)Patients who use of other DPP4 inhibitor
2)Patients who use of fibrate
3)Diabetic neuropathy
4)Severe ketosis,deabetic coma or precoma,type1diabetes
5)Severe renal dysfunction requiring hemodialysis or peritoneal dialysis
6)Severe hepatic dysfunction
7)Patients with a history of hypersensitibity to the study drug
8)Patients before or after operation, and those with severe infections or serious injury
9)Pregnant
10)Patients judged by the investigator to be ineligible for some other reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University Hospital
Division name
Dept. of Endocrinplogy and Diabetology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
i1901018@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University Hospital
Division name
Dept. of Endocrinplogy and Diabetology
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
Homepage URL
i1901018@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
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
Kumagaya Geka Hospital
Name of secondary funder(s)
None
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
埼玉医科大学（埼玉県）
熊谷外科病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007360
