UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000020382