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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017592
Receipt No. 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

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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
Email 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
Email odawara.tmu@gmail.com

Sponsor
Institute Tokyo medical university, Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Gerontology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020382

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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