UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014467 |
|---|---|
| Receipt number | R000016758 |
| Scientific Title | Research of second line anti-diabetes drug for patients with Type-2 diabetes who received Sitagliptin as first line. |
| Date of disclosure of the study information | 2014/07/03 |
| Last modified on | 2016/07/05 14:35:43 |
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Basic information
Public title
Research of second line anti-diabetes drug for patients with Type-2 diabetes who received Sitagliptin as first line.
Acronym
Research of second line anti-diabetes drug for patients with Type-2 diabetes who received Sitagliptin as first line.
Scientific Title
Research of second line anti-diabetes drug for patients with Type-2 diabetes who received Sitagliptin as first line.
Scientific Title:Acronym
Research of second line anti-diabetes drug for patients with Type-2 diabetes who received Sitagliptin as first line.
Region
| Japan |
Condition
Condition
Type II diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Both treatment of 50 mg of Sitagliptin and a diet therapy are provided more than three months, after than examine a combination of the second line of anti- diabetes drug which is added above in the patients when HbA1c is between 7-10%
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change and rate of change in HbA1c , 24 weeks later.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
15 mg / day of pioglitazone add to 50 mg / day of sitagliptin
Interventions/Control_2
0.5 mg / day of glimepiride add to 50 mg / day of sitagliptin
Interventions/Control_3
1000 mg / day of metformin add to 50 mg / day of sitagliptin
Interventions/Control_4
0.6 mg / day of voglibose add to 50 mg / day of sitagliptin
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
Outpatient with a diagnosis of type 2 diabetes.
More than three months of both treatment of 50mg of sitagliptin and adiet therapy
HbA1c 7-10%
Key exclusion criteria
Moderate to severe renal dysfunction
Dialysis patient
Medical history of heart failure,bowel obstruction
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sunao Matsubayashi |
Organization
Fukuoka Tokushukai Medical Center
Division name
Psychosomatic Medicine
Zip code
Address
4-5,sugukita,Kasuga City,Fukuoka,Japan
TEL
81925736622
s-kaku@csf.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoki Miyai |
Organization
Fukuoka Tokushukai Medical Center
Division name
internal medicine
Zip code
Address
4-5,sugukita,Kasuga City,Fukuoka,Japan
TEL
81925736622
Homepage URL
mizota@csf.ne.jp
Sponsor or person
Institute
Fukuoka Tokushukai Medical Center
Psychosomatic Medicine
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 03 | Day |
Last modified on
| 2016 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016758
