UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009332 |
|---|---|
| Receipt number | R000010957 |
| Scientific Title | Impact of Sitagliptin on Diabetes Mellitus in Japanese elderly patients |
| Date of disclosure of the study information | 2012/11/15 |
| Last modified on | 2017/05/19 10:51:11 |
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Basic information
Public title
Impact of Sitagliptin on Diabetes Mellitus in Japanese elderly patients
Acronym
SMILE STUDY
Scientific Title
Impact of Sitagliptin on Diabetes Mellitus in Japanese elderly patients
Scientific Title:Acronym
SMILE STUDY
Region
| Japan |
Condition
Condition
Type2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate efficacy and safety of sitagliptin in the glycaemic control of elderly type2 diabetes patients by researching circumstance of this treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
GA
Side effect, complication and its incidence rate
Key secondary outcomes
Weight, Blood pressure, Fasting plasma glucose, Compliance of diet therapy, Compliance of exercise therapy, Dose of sitagliptin, Concomitant drug for diabetic treatment, Reason for change agents, Concomitant drug for complication, GOT(AST), GPT(ALP), gammaGTP, U-Cre, U-Alb, Urine protein, Questionnaire
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patient of Type2 diabetes
2. The age between 65-90 years (Male and Female)
3. The patient who is insufficient glycemic control being diet and exercise therapy alone or, in combination with drug therapy
4. The patient who newly starts diabetes medical treatment with sitagliptin
Key exclusion criteria
1. The patient who has an anamnesis of sitaglitin allergy
2. The patient who has used incretin related drug in the past 3 month
3. The patient who has severe ketosis, diabetic coma or pre coma in the past 6 month
4. The patient has severe infection, before or after operation or severe external injury
5. The patient who has severe renal dysfanction
6. The patient of Type1 diabetes
7. The patient who is undertaking with glinide class
8. The patient is not allowed to this study by attending physician
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Saruta |
Organization
Japan Physicians Association
Division name
Chairman
Zip code
Address
13F Sumitomo Corporation,1-2-2 Hitotsubashi , Chiyoda-ku,Tokyo,Japan
TEL
03-5224-6110
setoyama@tenor.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takyama |
Organization
Soiken Inc.
Division name
Division of Clinical Study Support
Zip code
Address
NBF OGAWAMACHI BUILDING 4F, 1-3-1,Kanda Ogawamachi, Chiyoda-ku, Tokyo
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Japan Physicians Association
Institute
Department
Personal name
Funding Source
Organization
Japan Physicians Association
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 11 | Month | 15 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
HbA1c, GA, Side effect, complication and its incidence rate, Weight, Blood pressure, Fasting plasma glucose, Compliance of diet therapy, Compliance of exercise therapy, Dose of sitagliptin, Concomitant drug for diabetic treatment, Reason for change agents, Concomitant drug for complication, GOT(AST), GPT(ALP), gammaGTP, U-Cre, U-Alb, Urine protein, Questionnaire
Management information
Registered date
| 2012 | Year | 11 | Month | 14 | Day |
Last modified on
| 2017 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010957
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
