UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012642 |
|---|---|
| Receipt number | R000014781 |
| Scientific Title | Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes |
| Date of disclosure of the study information | 2013/12/21 |
| Last modified on | 2013/12/20 16:32:05 |
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Basic information
Public title
Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Acronym
Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Scientific Title
Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Scientific Title:Acronym
Effects of dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of sitagliptin in type 2 diabetes;1)BS control, 2) side effect outbreak situation such as the hypoglycemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of HbA1c
Key secondary outcomes
The change in
fasting blood glucose
Glycoalbumin (GA)
The weight
Glucagon
Insulin
C-peptide
Intact pro insulin(insulin/insulin ratio )
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
25mg of 50mg sitagliptin
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The type 2 diabetes patient whom blood sugar control is inadequate for
2) 20 years old or older
3) Sex no object
4) Outpatient
5) The patient that a written agreement was provided
Key exclusion criteria
1)ketotic diabetic coma severe within the past six months or patient with the previous comatose past
2)Severe infectious disease, before and after operation, patient with a serious injury
3)pregnant woman or a woman with the possibility of the pregnancy and the patient whom I am nursing
4)Patient(more than less than creatinine clearance 50ml/min, serum creatinine man 1.5mg/dL more than woman 1.3mg/dL) having renal function disorder more than medium degree
5)Patient during insulin prescription
6)Patient during A-GI,drugs prescription
7)It is a patient with a history of the past of hypersensitivity for an ingredient of the study medicine
8)The patient whom the chief physician assumed inappropriateness for study articipation in planning from medical grounds
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Namba |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology & Metabolism
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6592
ninai@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jyun-ichiro Miyagawa |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology & Metabolism
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6592
Homepage URL
miyagawa@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine,
Division of Diabetes, Endocrinology & Metabolism
Institute
Department
Personal name
Funding Source
Organization
Incretin Society in Hanshin
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2013 | Year | 12 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 20 | Day |
Last modified on
| 2013 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014781
