UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observation of using GLP-1 receptor agonist for wellness of brain activity in type 2 diabetes patients with mild cognitive impairment
Title of the study (Brief title)	Observation of using GLP-1 receptor Agonist for Wellness of brain Activity in type 2 diabetes patients with Mild Cognitive Impairment / OGAWA-MCI Study
Region	Japan

Condition
Condition	Type 2 diabetes mild cognitive impairment
Classification by specialty	Medicine in general Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to elucidate the efficacy of GLP-1 receptor agonist, dulaglutide, to cognitive function in type 2 diabetes patients with mild cognitive impairment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in Japanese version of Montreal Cognitive Assessment (MoCA-J) and Mini Mental State Examination (MMSE)
Key secondary outcomes	Group comparison of the following parameters before and after treatment 1)Physical examination Body weight, BMI, blood pressure, pulse rate and grip strength 2)Presence of symptomatic hypoglycemia 3)Hematology WBC, RBC, Hb, Ht, PLT 4)Biochemistry AST, ALT, LDH, gamma-GTP, TC, HDL-C, TG, LDL-C, Cyc-C, eGFRcyc, Cr, BUN, UA, Alb, Na, K, Cl, HbA1c, fasting blood glucose, fasting serum insulin, fasting serum C-peptide 5)vitamin B12, folic acid 6)TSH, FT3, FT4 7)Inflammatory markers IL-6, TNF-alpha, high sensitivity CRP 8)BNP 9)Urinalysis urine Cr, urine sodium, urine potassium, urine protein, urine albumin 10)Physiological test electrocardiogram (including CVR-R), ABI/PWV 11)Imaging study carotid duplex, head MRI, head MRA, VSRAD, cerebral blood flow scintigraphy 12)Adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	DPP-4 inhibitors and Sulfonylureas or Meglitinides will switch to Dulaglutide 0.75mg once weekly at the timing of obtained agreement in this study.
Interventions/Control_2	Treatment at obtaining consent is continued.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Type 2 diabetes 2)Patients with HbA1c 8.0% and below 3)Patients with mild cognitive impairment (MoCA-J score is from 18 to 25 and/or MMSE score is from 24 to 27) 4)Patients who are treated with DPP-4 inhibitors and Sulfonylureas or Meglitinides 5)Patient age is 65 years old or more at the timing of obtained agreement in this study 6)Patients having no dosing history of GLP-1 receptor agonist within 6 months 7)Patients whose medicine did not change during the last 3 months 8)Patients with BMI of 22.0 kg/m2 or higher
Key exclusion criteria	1)Type 1 diabetes or suspicion of Type 1 diabetes 2)Dosing of insulin injection 3)Suspicion of dementia (MoCA-J score is 17 and below and/or MMSE score is 23 and below) 4)Dosing of weekly DPP-4 inhibitor 5)Severe ketosis, diabetic coma or precoma 6)Clinical history of pancreatitis 7)Severe infectious disease, pre/post-surgery or serious trauma 8)Severe hepatic dysfunction 9)Pituitary or adrenal gland dysfunction 10)Status of dystrophy/starvation, irregular meal intake, dietary intake deficiency or hyposthenia 11)Excessive alcohol intake 12)Clinical history of allergy or hypersensitivity to GLP-1 receptor agonists 13)Pregnant/ possible pregnant, breastfeeding 14)Psychiatric disorder 15)Inappropriate patients for study participation judged by principal or clinical investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Takashi Sumita
Organization	Ogawa Red Cross Hospital
Division name	Department of Internal Medicine
Address	1525 Ogawa, Ogawa-machi, Hiki-gun, Saitama Japan
TEL	0493-72-2333
Email	sumi.jp@gmail.com

Public contact
Name of contact person	Takashi Sumita
Organization	Ogawa Red Cross Hospital
Division name	Department of Internal Medicine
Address	1525 Ogawa, Ogawa-machi, Hiki-gun, Saitama Japan
TEL	0493-72-2333
Homepage URL
Email	sumi.jp@gmail.com

Sponsor
Institute	Ogawa Red Cross Hospital
Institute
Department

Funding Source
Organization	Ogawa Red Cross Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 01 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 25 Day
Anticipated trial start date	2018 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 16 Day
Last modified on	2018 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035208