UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052156 |
|---|---|
| Receipt number | R000059527 |
| Scientific Title | Comparison of insulin degludec/liraglutide versus insulin degludec in multiple daily injection therapy on subjects with type 2 diabetes; time to reach target glycemic levels |
| Date of disclosure of the study information | 2023/09/09 |
| Last modified on | 2023/09/17 06:55:24 |
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Basic information
Public title
Comparison of insulin degludec/liraglutide versus insulin degludec in multiple daily injection therapy on subjects with type 2 diabetes; time to reach target glycemic levels
Acronym
Conparison of IDegLira vs IDeg in multiple daily injection therapy
Scientific Title
Comparison of insulin degludec/liraglutide versus insulin degludec in multiple daily injection therapy on subjects with type 2 diabetes; time to reach target glycemic levels
Scientific Title:Acronym
Conparison of IDegLira vs IDeg in multiple daily injection therapy
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the time to archive for glycemic target and total daily dose of insulin in multiple daily injection therapy; with insulin degludec/liraglutide versus insulin degludec, and to evaluate the therapeutic effect of each therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in the number of therapeutic days to achieve the glycemic target between the multiple injection therapy group with insulin degludec/liraglutide injection (IDegLira-MDI) and with insulin degludec.
Key secondary outcomes
1) Total daily dose of insulin when the target blood glucose was achieved.
2) Mean amplitude of glycemic excursions on a continuous glucose met
3) Other blood and urine tests (liver function, renal function, blood glucose, bone metabolism, secretory capacity, etc.)
4) ABI, CAVI, PWV in arteriosclerosis test
5) Body composition
6) Diurnal blood glucose variability index by treatment (%CV, M value, SD, ADRR(average daily risk range) in addition to MAGE)
7) 24-hour average blood glucose level
8) Percentage of time in target range (TIR)
9) Percentage of time below target range (TBR)
10) Percentage of time above target range (TAR)
11) Mean of daily difference of blood glucose
12) Blood glucose AUC, MAGE, SD, and MODD by time period
13) Relationships with patient background and laboratory values affecting the above data
14) Questionnaires related to diabetes treatment satisfaction and quality of life (DTR-QOL, eating behavior questionnaire)
15) Medications and blood/urine tests including HbA1c, weight, etc. in the outpatient clinic after completion of the treatments
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 subjects on treatment with oral hypoglycemic agents only
2) Subjects with HbA1c more than 7%
3) Subjects aged 20 years or older at the time of consent
4) Those who have received sufficient explanation before participating in this research, and who have obtained the voluntary consent of the research subject after receiving sufficient understanding, or who do not refuse to participate in the research.
Key exclusion criteria
1) Subjects on GLP-1 receptor agonists and insulin preparations as pre-treatment
2) Type 1 diabetes mellitus
3) Subjects who are deemed to be unsuitable by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Oe |
Organization
Kushiro Red Cross Hospital
Division name
Internal Medicine
Zip code
060-8638
Address
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
TEL
0154-22-7171
o-e.yuki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Oe |
Organization
Kushiro Red Cross Hospital
Division name
Internal Medicine
Zip code
060-8638
Address
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
TEL
0154-22-7171
Homepage URL
o-e.yuki@med.hokudai.ac.jp
Sponsor or person
Institute
Kushiro Red Cross Hospital
Institute
Department
Personal name
Yuki Oe
Funding Source
Organization
Kushiro Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
IRB Contact (For public release)
Organization
Ethics Committee of Kushiro Red Cross Hospital
Address
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
Tel
0154-22-7171
r.cross@kushiro.jrc.or.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a prospective, open-label, observational study.
Management information
Registered date
| 2023 | Year | 09 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059527
