UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial
Title of the study (Brief title)	Sitagliptin Effect on fatty liver and Lipid Metabolism study
Region	Japan

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

Objectives
Narrative objectives1	To compare effects of DPP4 inhibitor, sitagliptin and Sulfonylurea on intrahepatic adipose mass and lipid metabolism and fatty mass in patients with type 2 diabetes accompanied by fatty liver .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	amount of Intrahepatic adipose mass and visceral fat(MRI,DEXA)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	sitagliptin administration group
Interventions/Control_2	Glimepiride administration group
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)Inadequately controlled type 2 diabetic patients who are not taking antidiabetic agent other than metformin for more than 2 month. Patients whose HbA1c ranges from 6.9% to 9.4%. 2)Patients who had Fatty liver, or Patients whose IHL(intrahepatic lipid content)is more than 10% on 1H-MRS, or Patients who had metabolic syndrome fulfilled the diagnostic criteria, or Patients whose BMI is more than 25. 3)Patients who have been received diabetes treatment for more than 6 months. 4)over 20 years age 5)Out patient 6)Gender is not restricted. 7)Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start.
Key exclusion criteria	1)Patients who had diabetic ketosis, or diabetic pre-coma and coma within 6 months of the study entry. 2)Patients with severe infections, before or after operation, or with serious trauma. 3)Patients with pregnancy, possibility of pregnancy or having a breast feeding. 4)Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl) 5)Patients who received insulin therapy. 6)Patients who administered antihyperlipidemic agent other than Metformin for observation period. 7)Patients who had a history of hypersensitive reaction to DPP-4 inhibitor. 8)Patients whom the attending doctor estimated to be ineligible according to the medical rationale.
Target sample size	60

Research contact person
Name of lead principal investigator	Yasushi Tanaka
Organization	St.Marianna University School of Medicine
Division name	Division of Endocrinology and Metabolism
Address	2-16-1
TEL	044-977-8111
Email	h.k.kato@marianna-u.ac.jp

Public contact
Name of contact person	Hiroyuki Kato
Organization	St.Marianna University School of Medicine Hospital
Division name	Division of Endocrinology and Metabolism
Address	2-16-1 Sugou, Miyamae-ku Kawasaki-city Kanagawa-ken
TEL	044-977-8111
Homepage URL
Email	y2tanaka@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Kawasaki Diabetes Mellitus Square
Organization
Division
Category of Funding Organization	Other
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	聖マリアンナ医科大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 31 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 03 Month 06 Day
Last modified on	2017 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015584