General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus

Novo Nordisk

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin Icodec

Study type: Observational

Funder types: Industry

Identifiers

NCT06807190

NN1436-7680

U1111-1286-0463 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.

Enrollment: 630 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• The decision to initiate treatment with commercially available Awiqli has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
• Male or female with no age limitation.
• Diagnosis of diabetes mellitus. There is no limitation for type of diabetes mellitus and prior treatment for diabetes mellitus.

Exclusion criteria

• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Treatment with any investigational drug within 30 days prior to enrolment into the study.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• Contraindication described in Japanese package insert.
• Participants showing hypoglycaemic symptoms.
• Participants with a history of hypersensitivity to any ingredients of this drug.

Trial design

630 participants in 1 patient group

Awiqli

Description:

Participants with diabetes mellitus will be treated with commercially available Awiqli according to routine clinical practice at the discretion of the treating physician.

Treatment:

Drug: Insulin Icodec