UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of Sitagliptin on Diabetes Mellitus in Japanese elderly patients
Title of the study (Brief title)	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	Takao Saruta
Organization	Japan Physicians Association
Division name	Chairman
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	Hiroki Takyama
Organization	Soiken Inc.
Division name	Division of Clinical Study Support
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010957