UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060405 |
|---|---|
| Receipt number | R000069095 |
| Scientific Title | Exploration of an Outpatient Initiation and Titration Algorithm for Insulin Icodec in Japanese Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/19 22:40:01 |
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Basic information
Public title
Exploration of an Outpatient Initiation and Titration Algorithm for Insulin Icodec in Japanese Patients with Type 2 Diabetes
Acronym
Outpatient Initiation and Titration Algorithm for Insulin Icodec in Patients with Type 2 Diabetes
Scientific Title
Exploration of an Outpatient Initiation and Titration Algorithm for Insulin Icodec in Japanese Patients with Type 2 Diabetes
Scientific Title:Acronym
Outpatient Initiation and Titration Algorithm for Insulin Icodec in Patients with Type 2 Diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the Efficacy and Safety of a Body Weight Based Initiation and Glycemia Guided Titration Protocol Using Long-Acting Insulin Icodec in the Treatment of Type 2 Diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time in weeks to achieve target glycemic levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Insulin icodec is initiated at a dose of 1 unit/kg and titrated every two weeks according to the protocol, based on pre-breakfast blood glucose levels. The pre-breakfast blood glucose value is defined as the average of the measurements obtained on the day of insulin adjustment and the preceding day.
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) Patients who are able to provide written informed consent to participate in the study of their own free will.
2) Patients who meet the diagnostic criteria for type 2 diabetes mellitus.
3) Patients aged 20 years or older at the time informed consent is obtained.
4) Patients for whom insulin dose adjustment every two weeks after intervention is feasible.
Key exclusion criteria
1) Patients with contraindications to insulin icodec used in this study.
2) Patients with active malignancy.
3) Patients with severe hepatic or renal impairment that may affect the safety evaluation of the study drug.
4) Women who are pregnant or may be pregnant.
5) Breastfeeding women.
6) Patients receiving treatment with oral systemic corticosteroids.
7) Patients deemed ineligible by the principal investigator or sub-investigators for any other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsunehiko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kansai Rousai Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
660-8511
Address
Inabaso 3-chome 1-69, Amagasaki-city, Hyogo
TEL
06-6416-1221
yamamototunehiko@kansaih.johas.go.jp
Public contact
Name of contact person
| 1st name | Tsunehiko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kansai Rousai Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
660-8511
Address
Inabaso 3-chome 1-69, Amagasaki-city, Hyogo
TEL
06-6416-1221
Homepage URL
yamamototunehiko@kansaih.johas.go.jp
Sponsor or person
Institute
Kansai Rousai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Rousai Hospital
Address
Inabaso 3-chome 1-69, Amagasaki-city, Hyogo
Tel
06-6416-1221
yamamototunehiko@kansaih.johas.go.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 | 01 | 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 | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 19 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069095
