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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033779
Receipt No. R000038529
Scientific Title Comparison of glucose monitoring between insulin glargine U-300 and insulin degludec in the elderly patients with type 2 diabetes mellitus
Date of disclosure of the study information 2018/08/28
Last modified on 2018/08/16

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Basic information
Public title Comparison of glucose monitoring between insulin glargine U-300 and insulin degludec in the elderly patients with type 2 diabetes mellitus
Acronym Glucose monitoring in the elderly patients with type 2 diabetes mellitus using long-acting insulin
Scientific Title Comparison of glucose monitoring between insulin glargine U-300 and insulin degludec in the elderly patients with type 2 diabetes mellitus
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroaki Yagyu
Organization Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Division name Endocrinology and Metabolism
Zip code
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
1st name
Middle name
Last name Masanao Fujii
Organization Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Division name Department of Endocrinology and Metabolism
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
Results Delay Reason
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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 16 Day
Date of IRB
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

Other
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

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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