UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061951 |
|---|---|
| Receipt number | R000070804 |
| Scientific Title | The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections |
| Date of disclosure of the study information | 2026/06/18 |
| Last modified on | 2026/06/17 21:19:16 |
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Basic information
Public title
The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections
Acronym
The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections
Scientific Title
The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections
Scientific Title:Acronym
The Effect of Once-Weekly Basal Insulin Icodec on Glycemic Control in Japanese Patients with Type 2 Diabetes Undergoing Frequent Insulin Injections
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to gain new insights for future diabetes care by evaluating glycemic control, adherence, and insulin dosage in patients with type 2 diabetes currently receiving intensive insulin therapy, using once-weekly insulin icodec.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c 24 weeks after starting insulin icodec
Key secondary outcomes
The proportion of supplemental insulin in the total insulin dose. Additionally, changes in fasting blood glucose levels, body weight, BMI, treatment adherence, DTSQ scores, DTR-QOL scores, and supplemental insulin dose before starting Insulin Icodec and at 4, 12, and 24 weeks after initiation.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes
2. Patients aged 20 to 75 years at the time of obtaining informed consent
3. Patients who have been receiving continuous treatment with long-acting insulin and either ultra-rapid-acting or rapid-acting insulin for at least 12 weeks at the time of obtaining informed consent
4. Patients with an HbA1c level of 6.0% or higher but less than 10.0% at the time of obtaining informed consent
5. Patients who have the capacity to consent to participation in this study and are able to understand the consent form and other explanatory documents
Key exclusion criteria
1. Type 1 diabetes
2. Patients with a history of diabetic ketoacidosis within 90 days of obtaining informed consent
3. Patients with a history of hospitalization due to myocardial infarction, stroke, unstable angina, or transient ischemic attack within 180 days of obtaining informed consent
4. Patients with a history of pancreatic disease that affects blood glucose control
5. Patients with dementia
6. Pregnant women, women who may be pregnant, women planning to become pregnant, and breastfeeding women
7. Patients whom the attending physician has determined to have poor adherence
8. Any other patients whom the attending physician has determined to be unsuitable for participation in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | kota |
| Middle name | |
| Last name | takuma |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ots-ku, Tokyo
TEL
03-3762-4151
kota.takuma@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Takuma |
Organization
Toho University Omori Medical Center
Division name
Diabetes, Metabolism and Endocrinology Center
Zip code
143-8541
Address
6-11-1 Omorinishi, Ots-ku, Tokyo
TEL
03-3762-4151
Homepage URL
kota.takuma@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 Commitee of Toho University School of Medicine
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
Tel
03-3762-4151
kota.takuma@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 | 06 | Month | 18 | 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
| 2026 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 01 | 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 switched the treatment in accordance with the patient's wishes.
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070804
