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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010043
Receipt No. R000011762
Scientific Title Efficacy of liraglutide in non-insulin-dependent diabetic patients with GAD autoantibody -positive
Date of disclosure of the study information 2013/02/18
Last modified on 2016/10/01

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Basic information
Public title Efficacy of liraglutide in non-insulin-dependent diabetic patients with GAD autoantibody -positive
Acronym GRAPE study
(Group of liRAglutide Prevention and Evaluation Study)
Scientific Title Efficacy of liraglutide in non-insulin-dependent diabetic patients with GAD autoantibody -positive
Scientific Title:Acronym 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 Percentage of withdrawn patients whose HbA1c are over 9.4%(NGSP) at two consecutive times measurements and the term until withdrawal.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
1st name
Middle name
Last name Tetsuro Kobayashi
Organization University of Yamanashi, Faculty of Medicine
Division name Department of Internal Medicine III
Zip code
Address 1110 Shimokato, Chuo-City, Yamanashi, Japan
TEL 055-273-1111
Email tetsurou@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuro Kobayashi
Organization University of Yamanashi, Faculty of Medicine
Division name Department of Internal Medicine III
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Terminated
Date of protocol fixation
2012 Year 09 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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