UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058340 |
|---|---|
| Receipt number | R000066694 |
| Scientific Title | Evaluation of short-term changes in glycemic variability indices after switching from daily to once-weekly basal insulin: A multicenter, exploratory, prospective single-arm observational study |
| Date of disclosure of the study information | 2025/07/02 |
| Last modified on | 2025/07/02 08:24:26 |
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Basic information
Public title
Evaluation of short-term changes in glycemic variability indices after switching from daily to once-weekly basal insulin
Acronym
Evaluation of changes in glycemic variability indices after switching from daily to once-weekly basal insulin
Scientific Title
Evaluation of short-term changes in glycemic variability indices after switching from daily to once-weekly basal insulin: A multicenter, exploratory, prospective single-arm observational study
Scientific Title:Acronym
Evaluation of changes in glycemic variability indices after switching from daily to once-weekly basal insulin
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 switching to 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 blood glucose levels between the initial and second administration of insulin icodec.
Key secondary outcomes
Assessment -1: Pre-switching to insulin icodec
Assessment 1: After first dose of insulin icodec
Assessment 2: Before second dose of insulin icodec
Assessment 3: After second dose of 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 2and Assessment 3.
4) Changes in various CGM metrics from Assessment -1 to Assessments 1 through 3 (if pre-switch CGM data are available).
5) Daily intraday glycemic variability during each assessment period.
6) Changes in weekly insulin dose.
7) Changes in the CGM metrics stratified by insulin dose at switching.
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 who have been treated for at least two weeks with once-daily basal insulin and are using continuous glucose monitoring (CGM).
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
30
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
078-5810
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 | 02 | 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 | 05 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 28 | 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 | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066694
