UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060700 |
|---|---|
| Receipt number | R000069429 |
| Scientific Title | Evaluation of Treatment Efficacy, Including Patient Satisfaction with Once-Weekly Basal Insulin Icodec in Patients with Type 1 and Type 2 Diabetes |
| Date of disclosure of the study information | 2026/02/20 |
| Last modified on | 2026/02/18 14:36:25 |
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Basic information
Public title
Evaluation of Treatment Efficacy, Including Patient Satisfaction with Once-Weekly Basal Insulin Icodec in Patients with Type 1 and Type 2 Diabetes
Acronym
Evaluation of Treatment Efficacy, Including Patient Satisfaction with Once-Weekly Basal Insulin Icodec in Patients with Type 1 and Type 2 Diabetes
Scientific Title
Evaluation of Treatment Efficacy, Including Patient Satisfaction with Once-Weekly Basal Insulin Icodec in Patients with Type 1 and Type 2 Diabetes
Scientific Title:Acronym
Evaluation of Treatment Efficacy, Including Patient Satisfaction with Once-Weekly Basal Insulin Icodec in Patients with Type 1 and Type 2 Diabetes
Region
| Japan |
Condition
Condition
Type 1 and Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the efficacy and safety, including quality of life, in clinical practice of switching from daily basal insulin to weekly insulin icodec in patients with type 1 and type 2 diabetes undergoing insulin bolus therapy and continuous glucose monitoring (CGM).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in DTSQ and DTR-QOL scores before switching and 6 months after switching
Key secondary outcomes
Before switching and 1 month, 3 months, and 6 months after switching, confirm the following:
HbA1c, TIR (Time In Range: percentage of time within the target range (70-180 mg/dL)), TAR (Time Above Range: percentage of time above the TIR in the hyperglycemic range), TBR (Time Below Range: percentage of time below the TIR in the hypoglycemic range), fasting blood glucose, insulin dosage, weight
Safety evaluation items: Hypoglycemic episodes (number/duration, etc. of: self-reported hypoglycemia; Level 1 hypoglycemia (blood glucose <70 mg/dL persisting for 15 minutes or more without blood glucose <54 mg/dL, or occurring within 15 minutes); Level 2 hypoglycemia (blood glucose <54 mg/dL persisting for 15 minutes or more))
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
About Type 1 Diabetes
1. Patients with type 1 diabetes
2. Patients aged 18 years or older but under 75 years at the start of the study (at the time of ethics committee approval)
3. Patients undergoing treatment with frequent insulin injections
4. Patients with HbA1c <8.0% at the start of the study (at the time of ethics committee approval)
5. Patients capable of consenting to participate in this study and able to understand the consent form and other explanatory documents
About Type 2 Diabetes
1. Patients with Type 2 Diabetes
2. Patients aged 18 years or older at the start of the study (at the time of ethics committee approval)
3. Patients undergoing treatment with frequent insulin injections
4. Patients with HbA1c <10.0% at the start of the study (at the time of ethics committee approval)
5. Patients capable of consenting to participate in this study and able to understand the consent form and other explanatory documents
Key exclusion criteria
About Type 1 Diabetes
Patients meeting any of the following criteria are excluded from this study.
1. Type 2 diabetes
2. Heavy alcohol drinkers (pure alcohol intake of 60g/day or more for men, 30g/day or more for women)
3. Patients with dementia
4. Pregnant women, women who may be pregnant, women who wish to become pregnant, and breastfeeding women
5. Patients whose primary physician determines they have poor adherence
6. Other patients deemed unsuitable for participation in this study by the responsible physician
About Type 2 Diabetes
Patients meeting any of the following criteria are excluded from this study.
1. Type 1 diabetes
2. Heavy alcohol drinkers (pure alcohol intake of 60g/day or more for men, 30g/day or more for women)
3. Patients with dementia
4. Pregnant women, women who may be pregnant, women who wish to become pregnant, and breastfeeding women
5. Patients deemed to have poor adherence by their primary physician
6. Other patients deemed unsuitable for participation in this study by the responsible physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Iwata |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
youko.iwata@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Iwata |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
youko.iwata@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
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
Ethics Committee of Toho University School of Medicine
Address
6-11-1 Omori-nashi, Ota-Ku, Tokyo
Tel
03-3762-4151
youko.iwata@med.toho-u.ac.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
| 2026 | Year | 02 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study focuses on cases in which the attending physician determined that a change in treatment was necessary and the patient requested a change in treatment.
Management information
Registered date
| 2026 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069429
