UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033779 |
|---|---|
| Receipt number | 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 14:28:45 |
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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
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
mfujii1224@gmail.com
Sponsor or person
Institute
Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038529
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
