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Exploration of an Outpatient Initiation and Titration Algorithm for Insulin Icodec in Japanese Patients with Type 2 Diabetes

Exploration of an Outpatient Initiation and Titration Algorithm for Insulin Icodec in Japanese Patients with Type 2 Diabetes - Outpatient Initiation and Titration Algorithm for Insulin Icodec in Patients with Type 2 Diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060405
Enrollment
20
Registered
2026-01-20
Start date
2026-01-26
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

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

Sponsors

Kansai Rousai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Time in weeks to achieve target glycemic levels

Countries

Japan

Contacts

Public ContactTsunehiko Yamamoto

Kansai Rousai Hospital Department of Diabetes and Endocrinology

yamamototunehiko@kansaih.johas.go.jp06-6416-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026