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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009332
Receipt No. 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

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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
Email 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
Email takayama@soiken.com

Sponsor
Institute Japan Physicians Association
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010957

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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