UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058398 |
|---|---|
| Receipt number | R000066763 |
| Scientific Title | Evaluation of short-term changes in glycemic management indicators before and after initiating once-weekly basal insulin icodec: A multicenter, exploratory, prospective, single-arm observational study |
| Date of disclosure of the study information | 2025/07/08 |
| Last modified on | 2025/07/08 12:04:32 |
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Basic information
Public title
Evaluation of short-term changes in glycemic management indicators before and after initiating once-weekly basal insulin
Acronym
Evaluation of changes in glycemic management indicators before and after initiating once-weekly basal insulin
Scientific Title
Evaluation of short-term changes in glycemic management indicators before and after initiating once-weekly basal insulin icodec: A multicenter, exploratory, prospective, single-arm observational study
Scientific Title:Acronym
Evaluation of changes in glycemic management indicators before and after initiating once-weekly basal insulin icodec
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 evaluate the short-term efficacy and safety of initiating insulin icodec.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in 24-hour average glucose levels between pre-first-dose and pre-second-dose administration of insulin icodec.
Key secondary outcomes
Assessment 1: Pre-first-dose insulin icodec
Assessment 2: Post-first-dose insulin icodec
Assessment 3: Pre-second-dose insulin icodec
Assessment 4: Post-second-dose insulin icodec
1) Various CGM metrics will be assessed between Assessment 1 and Assessment 3, including Time in Range (TIR), Time Below Range (TBR), Time Above Range (TAR), Mean Amplitude of Glycemic Excursions (MAGE), Coefficient of Variation (%CV) for intraday glucose variability, Mean of Daily Differences (MODD) for inter day glucose variability.
2) Changes in various CGM metrics between Assessment 1 and Assessment 2.
3) Changes in various CGM metrics between Assessment 2 Assessment 3.
4) Changes in various CGM metrics between Assessment 2 Assessment 4.
5) Daily intraday glycemic variability during each assessment period.
6) Changes in weekly insulin dose.
7) Changes in average glucose levels and glycemic variability according to insulin dose.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes with HbA1c levels of 7% or higher who are scheduled to initiate insulin icodec
Key exclusion criteria
1) Type 1 diabetes
2) Gestational diabetes
3) Diabetic ketoacidosis
4) Inappropriate as study subjects by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Asahikawa Medical University Hospital
Division name
Department of diabetology and endocrinology
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL
0166-65-2111
hnomoto@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Asahikawa Medical University Hospital
Division name
Department of diabetology and endocrinology
Zip code
078-8510
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL
0166-65-2111
Homepage URL
hnomoto@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido
Tel
0166-68-2297
rs-kp.g@asahikawa-med.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
旭川医科大学病院（北海道）、旭川厚生病院（北海道）、市立旭川病院（北海道）、旭川赤十字病院（北海道）、北海道大学病院（北海道）、さっぽろ糖尿病・甲状腺クリニック（北海道）、栗原内科（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 08 | 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
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 23 | 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
Blood glucose indices at each assessment period will be presented as mean +- standard deviation or as median with interquartile range (25th-75th percentiles). Differences between time points will be analyzed using paired t-tests or Wilcoxon signed-rank tests, as appropriate. For analyses involving more than two groups, repeated measures ANOVA or the Friedman test will be conducted, with additional post hoc analyses as necessary.
Management information
Registered date
| 2025 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066763
