UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of second line anti-diabetes drug for patients with Type-2 diabetes who received Sitagliptin as first line.
Title of the study (Brief title)	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

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	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

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	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	Sunao Matsubayashi
Organization	Fukuoka Tokushukai Medical Center
Division name	Psychosomatic Medicine
Address	4-5,sugukita,Kasuga City,Fukuoka,Japan
TEL	81925736622
Email	s-kaku@csf.ne.jp

Public contact
Name of contact person	Hitoki Miyai
Organization	Fukuoka Tokushukai Medical Center
Division name	internal medicine
Address	4-5,sugukita,Kasuga City,Fukuoka,Japan
TEL	81925736622
Homepage URL
Email	mizota@csf.ne.jp

Sponsor
Institute	Fukuoka Tokushukai Medical Center Psychosomatic Medicine
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

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 03 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016758