UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003123 |
|---|---|
| Receipt number | R000001329 |
| Scientific Title | Phase II clinical trial of nasal GLP-1 in type 2 diabetes |
| Date of disclosure of the study information | 2010/02/01 |
| Last modified on | 2010/02/01 13:55:43 |
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Basic information
Public title
Phase II clinical trial of nasal GLP-1 in type 2 diabetes
Acronym
JNAS71
Scientific Title
Phase II clinical trial of nasal GLP-1 in type 2 diabetes
Scientific Title:Acronym
JNAS71
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess exploratively the efficiency and safety of nasal GLP-1, JNASE7001, in type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
glycoalbumin
1,5-AG
amount of meal
Key secondary outcomes
plasma glucose
insulin concentration
glucagon concentration
lipid profile
body weight and body composition
level of hunger
appetite score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nasal GLP-1(recombinant)
Interventions/Control_2
placebo
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. type 2 diabetes in accordance with WHO criteria who are treated with oral anti-diabetic agents
2. HbA1c 6.5~9.0%
3. age between 20 and 70 years old
4. out-clinic patient
5. informed consent
Key exclusion criteria
1. type 1 diabetes
2. brittle diabetes
3. patients who need insulin therapy
4. problems in nasal cavity
5. bronchial asthma
6. preproliferative and proliferative diabetic retinopathy
7. chronic renal failure(serum CRE>3.0mg/dl) and who are treated with hemodialysis
8. acute myocardial infarction, unstable angina, acute coronary syndrome
9. obstruction of gastrointestinal tract
10. tube feeding or intravenous hyperalimentation
11. neoplasm
12. severe liver injury
13. chronic alcoholism or drug abuse
14. drug allergy
15. pregnant or in the lactation period
16. capability of pregnancy
17. history of other clinical trials within 2 months prior to the informed consent
18. patients whom the physician judges to be ineligible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamitsu Nakazato |
Organization
University of Miyazaki Faculty of Medicine
Division name
The 3rd Dept of Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
0985-85-2965
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanari Mizuta |
Organization
University of Miyazaki Faculty of Medicine
Division name
The 3rd Dept of Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
0985-85-2965
Homepage URL
mmizuta@fc.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2008 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 01 | Day |
Last modified on
| 2010 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001329
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| Registered date | File name |
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| Registered date | File name |
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