UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of glucose monitoring between insulin glargine U-300 and insulin degludec in the elderly patients with type 2 diabetes mellitus
Title of the study (Brief title)	Glucose monitoring in the elderly patients with type 2 diabetes mellitus using long-acting insulin
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of glucose monitoring between two types of long-acting insulin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean amplitude of glycemic excursion
Key secondary outcomes	Mean of daily difference, average blood glucose, standard deviation, hypoglycemia with glucose value less than 70 mg/dl

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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	Patients requiring insulin glargine U-300 for 7 days
Interventions/Control_2	Patients requiring insulin degludec for 7 days
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients aged 65 and older treating with basal oral therapy using insulin glargine or insulin degludec
Key exclusion criteria	1. Patients who have diabetic ketosis or diabetic coma. 2. Patients with severe infection, severe injury or perioperative state. 3. Patients with severe diabetic complications such as neuropathy, retinopathy, and nephropathy. 4. Patients with severe hepatic, kidney, or cardiac diseases. 5. Pregnant. 6. Patients whom researchers rule out as inappropriate subjects.
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroaki Yagyu
Organization	Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Division name	Endocrinology and Metabolism
Address	3-2-7 Miya-machi, Mito, Ibaraki, Japan 310-0015
TEL	029-231-2371
Email	hiroakiyagyu@md.tsukuba.ac.jp

Public contact
Name of contact person	Masanao Fujii
Organization	Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Division name	Department of Endocrinology and Metabolism
Address	3-2-7 Miyamachi, Mito, Ibaraki, Japan 310-0015
TEL	029-231-2371
Homepage URL
Email	mfujii1224@gmail.com

Sponsor
Institute	Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Institute
Department

Funding Source
Organization	Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Organization
Division
Category of Funding Organization	Self funding
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 08 Month 28 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 05 Month 16 Day
Anticipated trial start date	2018 Year 09 Month 01 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 08 Month 16 Day
Last modified on	2018 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038529