UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058383 |
|---|---|
| Receipt number | R000066723 |
| Scientific Title | Efficacy and safety of weekly basal insulin icodec in elderly type 2 diabetes patients with insufficient self-management of insulin therapy |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/07 11:01:38 |
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Basic information
Public title
Efficacy and safety of weekly basal insulin icodec in elderly type 2 diabetes patients with insufficient self-management of insulin therapy
Acronym
Efficacy and safety of weekly basal insulin icodec in elderly type 2 diabetes patients with insufficient self-management of insulin therapy
Scientific Title
Efficacy and safety of weekly basal insulin icodec in elderly type 2 diabetes patients with insufficient self-management of insulin therapy
Scientific Title:Acronym
Efficacy and safety of weekly basal insulin icodec in elderly type 2 diabetes patients with insufficient self-management of insulin therapy
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the efficacy and safety of once-weekly basal insulin icodec under real-world clinical conditions in elderly patients with type 2 diabetes who have insufficient self-management of their insulin therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c from baseline at 24 weeks of intervention
Key secondary outcomes
The following will be checked at baseline, 12 weeks, and 24 weeks.
1.Glycemic evaluation parameters: HbA1c (except at 24 weeks), fasting blood glucose level by SMBG (Self-Monitoring of Blood Glucose)
2.Other major laboratory parameters: ALT, AST, gamma-GTP, T-CHO, HDL-C, TG, FwLDL-C, Cre, eGFR, UA, serum albumin, urinary albumin, hemoglobin
3.Body weight, BMI
4.Blood pressure, pulse rate
5.Frequency of hypoglycemia (assessed by medical interview)
6.Occurrence of adverse events
7.Questionnaire to evaluate caregiver satisfaction (STCD2-J)
In addition to the above, glycemic profiles during the initial phase will be observed using CGM (Continuous Glucose Monitoring), with a particular focus on confirming the occurrence of hypoglycemia (including Time Below Range [TBR] values).
Furthermore, an exploratory analysis of factors associated with hypoglycemia will be conducted.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from existing basal insulin therapy to insulin icodec, a weekly subcutaneous basal insulin analogue.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Outpatients with type 2 diabetes at Amami Central Hospital.
2.Patients who have difficulty with self-management of their treatment and require assistance from family or home-visit nursing care.
3.Patients aged 65 years or older (based on age at the date of consent).
4.Patients who, or whose family members, have the capacity to consent to participate in the study and are able to understand the informed consent form and other explanatory documents.
5.Patients who have been treated with once-daily basal insulin for the past three months and have not used any other types of insulin.
6.Patients with a baseline HbA1c of 6.5% or higher and less than 10.0%.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study:
1.Patients with type 1 diabetes.
2.Patients with severe liver disease, or those with AST (GOT) or ALT (GPT) levels of 100 IU/L or higher.
3.Patients with severe renal disease, or those with a serum creatinine level of 2.0 mg/dL or higher.
4.Patients with manifest heart failure or those who have had a myocardial infarction within 3 months prior to the study start.
5.Patients with severe pancreatic disease.
6.Patients with acute or severe medical conditions that may affect glycemic control.
7.Patients with severe infections, severe trauma, or those in the perioperative period.
8.Patients with severe chronic intestinal diseases such as inflammatory bowel disease, colonic ulcer, localized intestinal obstruction, predisposition to intestinal obstruction, or conditions associated with digestive/absorptive abnormalities.
9.Habitual heavy alcohol drinkers (e.g., an average daily consumption of more than 3 'go' of sake, 3 large bottles of beer, 3 double whiskies, 6 glasses of wine, or 2 'go' of shochu).
10.Patients with a baseline BMI of 30 kg/m2 or higher.
11.Patients with a baseline basal insulin dose exceeding 30 units/day.
12.Patients who experience one or more episodes of hypoglycemia per week during the baseline period.
13.Other patients deemed unsuitable for the study by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Genki |
| Middle name | |
| Last name | Sato |
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
genki.sato@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Genki |
| Middle name | |
| Last name | Sato |
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
genki.sato@med.toho-u.ac.jp
Sponsor or person
Institute
Amami Central Hospital
Department of Diabetes
Akiko Tsuchiya
Institute
Department
Personal name
Akiko Tsuchiya
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
med.rinri@ext.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
| 2025 | Year | 07 | Month | 07 | 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
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066723
