UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006799 |
|---|---|
| Receipt number | R000008046 |
| Scientific Title | Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide in type 2 diabetes: a CGM based-study |
| Date of disclosure of the study information | 2011/12/05 |
| Last modified on | 2016/06/02 14:50:44 |
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Basic information
Public title
Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide in type 2 diabetes: a CGM based-study
Acronym
Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide
Scientific Title
Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide in type 2 diabetes: a CGM based-study
Scientific Title:Acronym
Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effect of sitagliptin and nateglinide or liraglutide and exenatide on glycemic control and safety in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Standard deviation of blood glucose by CGM
Key secondary outcomes
1)averate blood glucose, MAGE by CGM
2)FPG and PPG at 1, 2, 3, 4, 5, 6, 7 days of treatment
3)%chagne of FPG, HbA1c,IRI,CPR, a from baseline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sitagliptin 50mg for 4 months
From 2nd day of a medication start, all patients are equiped with a CGM for four days. SMBG is also done 6 times per day. If FPG is more than 130mg/dl or PPG is more than 180mg/dl, other hypoglycemic agents is consider to add. HbA1c is measured 2 or 4 months after a medical treatment start
Interventions/Control_2
nateglinide 270mg/day for 4 months
Interventions/Control_3
liraglutide0.3, 0.6, 0.9mg/day for 4 months
Interventions/Control_4
exenatide 10ug/day for 4 months
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)before test registration - the meal and exercise cure for one month or more or a meal and an exercise cure, and diabetic medicine (aTZD,BG,SU, alpha-GI) and inpatient
2)HbA1c (JDS):more than 6.6%, less than 16.6%
3)Type 2 diabetes
4)Pts with written IC
5)Age more than 20, less than 85
Key exclusion criteria
1)severe ketosis, diabetic coma within 6 months
2)severe infection, before operation, severe trauma
3)severe hepatic dysfunction
4)or severe renal dysfunction (eGFR: more than 1.5mg/dl)
5)Patients who use of insulin
6)pregnacy
7)Allergy for sitagliptin, nateglinide,liraglutide and exenatide
8)Patients judged by the investigator to be ineligible for some other reason
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
yamakat@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Erina Shigematu |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
erina-sgmt@live.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
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
横浜市立大学附属市民総合医療センター（神奈川県）
横須賀市立市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/63/3/63_EJ15-0500/_article
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 | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | 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 | 11 | Month | 30 | Day |
Last modified on
| 2016 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008046
