UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide in type 2 diabetes: a CGM based-study
Title of the study (Brief title)	Comparison of DPP-4 inhibitor, sitagliptin and nateglinide, and liraglutide and exenatide
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare the effect of sitagliptin and nateglinide or liraglutide and exenatide on glycemic control and safety in patients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Standard deviation of blood glucose by CGM
Key secondary outcomes	1)averate blood glucose, MAGE by CGM 2)FPG and PPG at 1, 2, 3, 4, 5, 6, 7 days of treatment 3)%chagne of FPG, HbA1c,IRI,CPR, a from baseline

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	sitagliptin 50mg for 4 months From 2nd day of a medication start, all patients are equiped with a CGM for four days. SMBG is also done 6 times per day. If FPG is more than 130mg/dl or PPG is more than 180mg/dl, other hypoglycemic agents is consider to add. HbA1c is measured 2 or 4 months after a medical treatment start
Interventions/Control_2	nateglinide 270mg/day for 4 months
Interventions/Control_3	liraglutide0.3, 0.6, 0.9mg/day for 4 months
Interventions/Control_4	exenatide 10ug/day for 4 months
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)before test registration - the meal and exercise cure for one month or more or a meal and an exercise cure, and diabetic medicine (aTZD,BG,SU, alpha-GI) and inpatient 2)HbA1c (JDS):more than 6.6%, less than 16.6% 3)Type 2 diabetes 4)Pts with written IC 5)Age more than 20, less than 85
Key exclusion criteria	1)severe ketosis, diabetic coma within 6 months 2)severe infection, before operation, severe trauma 3)severe hepatic dysfunction 4)or severe renal dysfunction (eGFR: more than 1.5mg/dl) 5)Patients who use of insulin 6)pregnacy 7)Allergy for sitagliptin, nateglinide,liraglutide and exenatide 8)Patients judged by the investigator to be ineligible for some other reason
Target sample size	80

Research contact person
Name of lead principal investigator	Tadashi Yamakawa
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	yamakat@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	Erina Shigematu
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	erina-sgmt@live.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	横浜市立大学附属市民総合医療センター（神奈川県） 横須賀市立市民病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 01 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2015 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/endocrj/63/3/63_EJ15-0500/_article
Results
Other related information

Management information
Registered date	2011 Year 11 Month 30 Day
Last modified on	2016 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008046