UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of liraglutide in non-insulin-dependent diabetic patients with GAD autoantibody -positive
Title of the study (Brief title)	GRAPE study (Group of liRAglutide Prevention and Evaluation Study)
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of once daily liraglutide and once daily insulin glargine in diabetes patients with GAD antibody positive diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in s-CPR after oral glucose tolerance test
Key secondary outcomes	1. Percentage of withdrawn patients whose HbA1c are over 9.4%(NGSP) at two consecutive times measurements and the term until withdrawal. 2. Change in blood glucose level after oral glucose tolerance test every 6-month. 3. Change in HbA1c 4. Change in fasting plasma glucose 5. Change in fasting s-CPR 6. Change in circadian variability of blood-glucose 7. Change in weight 8. Change in blood pressure. 9. Change in islet autoantibodies (GAD antibody, IA-2 antibody, Insulin antibody, ZnT8 antibody)

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	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Once-daily administration of liraglutide (morning or evening)
Interventions/Control_2	Once-daily administration of insulin glargine (before breakfast)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. HbA1c(NGSP): 6.5%<= and <9.0% 2. GAD antibody positive (>=1.5U/mL) and fasting s-CPR >=1.0ng/mL 3. Duration of diabetes: 6 months<= and <=10 years 4. Age: 20<= and <80 years old 5. Patients who can washout OADs (sulfonylurea, biguanide, alpha-glucosidase inhibitor, gulinide, pioglitazone, DPP-4 inhibitor) or insulin therapy more than 1-month (1-week in case of insulin) before the entry. 6. Patients without history of liraglutide, exenatide or lixisenatide treatment
Key exclusion criteria	1. Ketosis 2. Pregnant, or intention of becoming pregnant 3. Patients who has serious complication or concurrent disease 4. Any other condition which the investigator feels would interfere with the participation.
Target sample size	60

Research contact person
Name of lead principal investigator	Tetsuro Kobayashi
Organization	University of Yamanashi, Faculty of Medicine
Division name	Department of Internal Medicine III
Address	1110 Shimokato, Chuo-City, Yamanashi, Japan
TEL	055-273-1111
Email	tetsurou@yamanashi.ac.jp

Public contact
Name of contact person	Tetsuro Kobayashi
Organization	University of Yamanashi, Faculty of Medicine
Division name	Department of Internal Medicine III
Address	1110 Shimokato, Chuo-City, Yamanashi, Japan
TEL	055-273-1111
Homepage URL
Email	tetsurou@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi, Faculty of Medicine Department of Internal Medicine III
Institute
Department

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	埼玉医科大学附属病院（埼玉県）、近畿大学医学部附属病院（大阪府）、長崎大学病院（長崎県）、 東京都済生会中央病院（東京都）心臓病センター 榊原病院（岡山県）、市立札幌病院（北海道）、HECサイエンスクリニック（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 09 Month 30 Day
Anticipated trial start date	2013 Year 02 Month 25 Day
Last follow-up date	2015 Year 12 Month 31 Day
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	2013 Year 02 Month 14 Day
Last modified on	2016 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011762