UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017592 |
|---|---|
| Receipt number | R000020382 |
| Scientific Title | The effect of the cognitive function of GLP-1 receptor agonist in Type 2 diabtes patients with mild cognitive dysfunction. - prospective,randomized,active-controlled study - |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2019/12/13 16:22:09 |
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Basic information
Public title
The effect of the cognitive function of GLP-1 receptor agonist in Type 2 diabtes patients with mild cognitive dysfunction. - prospective,randomized,active-controlled study -
Acronym
GLP-1 receptor agonist in Type 2 diabtes patients with mild cognitive dysfunction. - prospective,randomized,active-controlled study -
Scientific Title
The effect of the cognitive function of GLP-1 receptor agonist in Type 2 diabtes patients with mild cognitive dysfunction. - prospective,randomized,active-controlled study -
Scientific Title:Acronym
GLP-1 receptor agonist in Type 2 diabtes patients with mild cognitive dysfunction. - prospective,randomized,active-controlled study -
Region
| Japan |
Condition
Condition
Type 2 diabetes with mild cognitive disfunction
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect on cognitive function of GLP-1RA or ultra-rapid insulin in type 2 diabetes patients with cognitive dysfunction after basal insulin with/without oral antidiabetic agents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of cognitive function(MMSE,DSST,Moca-J,GDS-15,TMT-A,TMT-B)
Key secondary outcomes
Change of cerebral blood flow(MRI,SPECT)
Blood glucose(HbA1c,Fasting blood glucose, post-prandial blood glucose, SMBG)
Glycoalbumin, 1,5-anhydroglcitol,
C-peptide, hypoglycemic episode, QOL(DTSQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lixisenatide administration
Interventions/Control_2
ultra-rapid insulin administration
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
1.Type 2 diabetes treated with Basal insulin with/without oral antidiabetic agents for more than 3 months
2.Patients whose taken SU is discontinued
3.Patients whose HbA1c 7.0% <= HbA1c < 10.0% at the enrollment
4.Patients whose FPG 110mg/dl <= FPG < 180mg/dl
5. Patients without severe cardiac disease,severe hepatic disorder,severe renal disease.
6. Patients who can possess the agreement ability and get consent by a document
7. Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
8.Outpatients
Key exclusion criteria
1.Patients who are not Type 2 diabetes
2.Excessive common custom drinker
3.Patients having a cancer
4. Patients with severe diabetic complication.
5.Patients with severe renal disease or severe liver disease
6. History of chemical sensitivity to antidiabetic drugs.
7. Women who are pregnant or nursing or could become pregnant.
8. Determined to be ineligible by the physician in charge for any other reason.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Odawara |
Organization
Tokyo medical university hospital
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
1600023
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku ,Tokyo, 160-0023, Japan
TEL
0333426111
odawara.tmu@gmail.com
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Odawara |
Organization
Tokyo medical university hospital
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
1600023
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku ,Tokyo, 160-0023, Japan
TEL
0333426111
Homepage URL
odawara.tmu@gmail.com
Sponsor or person
Institute
Tokyo medical university, Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Gerontology
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
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo
Tel
0333426111
kenkyu-s@tokyo-med.ac.jp
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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
| Delay expected |
Results Delay Reason
There were no participants
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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 15 | Day |
Last modified on
| 2019 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020382
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| Registered date | File name |
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