UMIN-CTR Clinical Trial

Basic information
Public title	Sitagliptin Use and its Continuous Glycemic Control Effcets in Japanese patients with type 2 diabetes in Saitama
Acronym	SUCCEED trial
Scientific Title	Sitagliptin Use and its Continuous Glycemic Control Effcets in Japanese patients with type 2 diabetes in Saitama
Scientific Title:Acronym	SUCCEED trial
Region	Japan

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

Objectives
Narrative objectives1	Efficacy of sitagliptin monotherapy in maintaining long-term glycemic control in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. To achieve HbA1c less than 7.0% (JDS values) at 12 weeks after treatment with sitagliptin 2. The time to monotherapy failure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Duration: 104 weeks Therapy: Sitagliptin 50 mg/day
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with the ages of more than 20 years. 2. Patients who do not recieve any anti-diabetic agent within 1 month. 3. HbA1c levels (JDS values) ranging from 6.5 to 7.9 % at baseline. 4. Both outpatients and inpatients
Key exclusion criteria	1. Patients with type 1 diabetes 2. Renal impairment (Serum creatinine more than 1.5 mg/dl in men or 1.3 mg/dl in women) 4. Patients who undergo surgery 5. Preganat women
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Yoshimasa Middle name Last name Aso
Organization	Dokkyo Medical University, Koshigaya Hospital
Division name	Internal Medicine
Zip code	343-8555
Address	2-1-50 Minami-Koshigaya, Koshigaya, Saitama, Japan
TEL	048-965-111
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Kozo Middle name Last name Takebayashi
Organization	Dokkyo Medical University,
Division name	Internal Medicine
Zip code	343-8555
Address	2-1-50 Minami-Koshigaya, Koshigaya, Saitama, Japan
TEL	048-965-1111
Homepage URL
Email	takebaya@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University,Koshigaya Hospital
Institute
Department

Funding Source
Organization	Dokkyo Medical University,Koshigaya Hopital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Medical Center, Dokkyo Medical University
Address	2-1-50 Minami Koshigaya, Koshigaya
Tel	048-965-1111
Email	yaso@dokkyomed.ac.jp

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	2011 Year 02 Month 14 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	50
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	2011 Year 01 Month 19 Day
Date of IRB	2010 Year 12 Month 20 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2019 Year 08 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 02 Month 14 Day
Last modified on	2019 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006040