UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008474 |
|---|---|
| Receipt number | R000009920 |
| Scientific Title | Effect of repaglinide or sitagliptin upon glycemic control in Japanese patients with type 2 diabetes mellitus. |
| Date of disclosure of the study information | 2012/08/21 |
| Last modified on | 2015/01/27 17:44:00 |
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Basic information
Public title
Effect of repaglinide or sitagliptin upon glycemic control in Japanese patients with type 2 diabetes mellitus.
Acronym
Glycemic control with repaglinide or sitagliptin.
Scientific Title
Effect of repaglinide or sitagliptin upon glycemic control in Japanese patients with type 2 diabetes mellitus.
Scientific Title:Acronym
Glycemic control with repaglinide or sitagliptin.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the glycemic control in Japanese type 2 diabetes mellitus treated with repaglinide or sitagliptin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c(NGSP)
1,5AG
8-iso-prostaglandin F2a
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Repaglinide: 0.75-1.5 mg/day (can be increased up to 3 mg/day if necessary) for 24 weeks.
Interventions/Control_2
Sitagliptin: 50 mg/day (can be increased up to 100 mg/day if necessary) for 24 weeks.
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
Type 2 diabetes patients, attending the OPD of the Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School Hospital, insufficienttly controlled (HbA1c(NGSP) less than 8.4%) with alimentary therapy or with alpha-glucosidase inhibitors.
Key exclusion criteria
1) Type1 diabetes mellitus.
2) Patients with serious ketosis, diabetic coma, or pre-coma.
3) Patients with severe infection, before and after surgery, or severe injury.
4) Patients with pregnancy or lactating.
5) Patients with severe hepatic dysfunction.
6) Patients with renal impairment.
7) Patients treated with insulin.
8) Patients who has a history of adverse events with each drugs.
9) Patients who has a history of hypersensitivity to each drugs.
10) Patients who are judged unsuitable to participate the trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Hashiramoto |
Organization
Kawasaki Medical School Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
577 Matsushima, Kurashiki 701-0192, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Hashiramoto |
Organization
Kawasaki Medical School Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
577 Matsushima, Kurashiki 701-0192, Japan
TEL
Homepage URL
hashira@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School Hospital
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
川崎医科大学病院(岡山県) (Kawasaki Medical School Hospital, Okayama, Japan)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | 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
Per test planner retirement
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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 19 | Day |
Last modified on
| 2015 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009920
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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