UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010043 |
|---|---|
| Receipt number | 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 15:13:02 |
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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 Percentage of withdrawn patients whose HbA1c are over 9.4%(NGSP) at two consecutive times measurements and the term until withdrawal.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
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
tetsurou@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi, Faculty of Medicine
Department of Internal Medicine III
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011762
