UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of GLP-1 receptor agonist in combination with insulin on abdominal fat in patients with type 2 diabetes trial
Title of the study (Brief title)	GLP-1 receptor agonist and abodominal fat in diabetes
Region	Japan

Condition
Condition	Patients with type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of liraglutide on the abdominal fat accumulation and hepatic fat deposit in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in visceral fat area 24 after administration of liraglutide
Key secondary outcomes	The change in liver attenuation index 24 after administration of liraglutide

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Liraglutide 0.9 mg added to insulin treatment
Interventions/Control_2	insulin alone
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	Type 2 diabetic patients treated with insulin whose HbA1c levels are between 7 and 10% and BMI levels are> or = 25 kg/m2
Key exclusion criteria	Type 1 diabetes Patients with allergy to incretin mimetics Patients with interstitial pneumonia Patints with liver chirrosis or renal failure Patients who had experienced acute coronary syndrome or stroke or acute pancreatitis within 3 months prior to enrollment Patients with malignant neoplasms Patients who are alread treated with DPP4 inhibitors and/or GLP-1 receptor agonists. Patients whose dosage of insulin has been changed by > 20 % within 3 months prior to enrollment
Target sample size	100

Research contact person
Name of lead principal investigator	Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Departmet of Molecular Endocrinology and Metabolism
Address	1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL	03-3813-6111
Email	bouchi.mem@tmd.ac.jp

Public contact
Name of contact person	Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Departmet of Molecular Endocrinology and Metabolism
Address	1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL	03-3813-6111
Homepage URL
Email	bouchi.mem@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
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 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 06 Day
Anticipated trial start date	2014 Year 12 Month 15 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	https://www.ncbi.nlm.nih.gov/pubmed/27916783
Results	Liraglutide treatment significantly reduced visceral fat area (VFA) at 24 weeks; whereas, subcutaneous fat are (SFA) was unchanged. albuminuria, liver attenuation index, and CRP levels were significantly reduced by liraglutide at 24 weeks and there was no difference in skeletal muscle index between the two groups.
Other related information

Management information
Registered date	2014 Year 12 Month 06 Day
Last modified on	2016 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018463