Evaluation of short-term changes in glycemic management indicators before and after initiating once-weekly basal insulin

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 - Evaluation of changes in glycemic management indicators before and after initiating once-weekly basal insulin icodec

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058398

Enrollment

Registered

2025-07-08

Start date

2025-06-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes with HbA1c levels of 7% or higher who are scheduled to initiate insulin icodec

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes 2) Gestational diabetes 3) Diabetic ketoacidosis 4) Inappropriate as study subjects by the principal investigator

Design outcomes

Primary

Measure	Time frame
The change in 24-hour average glucose levels between pre-first-dose and pre-second-dose administration of insulin icodec.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactHiroshi Nomoto

Asahikawa Medical University Hospital Department of diabetology and endocrinology

hnomoto@asahikawa-med.ac.jp0166-65-2111

Outcome results