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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006217
Receipt No. 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 2013/09/25

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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
Email 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
Email i1901018@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
Email

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
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
2013 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007360

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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