Awiqli (insulin icodec) use and results in people with diabetes in Japan.

A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan

This study will test Awiqli (insulin icodec) in people with diabetes to see if it's safe and works well during routine care in Japan.

Quick facts

• Study type: Observational
• Enrollment: 630 (estimated)
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 80 sites (Koriyama-shi, Fukushima, Fukushima, Japan and 79 other locations)
• Trial ID: NCT06807190 on ClinicalTrials.gov

What this trial studies

This is an observational, real-world follow-up of people who are prescribed Awiqli (insulin icodec) by their treating physician, with data collection over about one year. Participants receive Awiqli as decided by their doctor outside of the study, and the study records safety and effectiveness outcomes from routine clinical practice. Eligibility is broad with no age limits and includes people with any type of diabetes, while excluding those with recent investigational drug use or contraindications listed in the Japanese product information. Data will be collected at participating clinical sites in Japan to describe how Awiqli performs in everyday care.

Who should consider this trial

Good fit: People of any age with diabetes in Japan who have already decided with their doctor to start commercially available Awiqli (insulin icodec) are typical candidates for this follow-up.

Not a fit: Patients with contraindications per the Japanese package insert, recent participation in other investigational drug trials, or who cannot give informed consent are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the results could help doctors and patients understand how well Awiqli works and how safe it is when used in routine clinical practice.

How similar studies have performed: Controlled clinical trials of insulin icodec have shown promising efficacy and safety, but real-world post-marketing data remain more limited.

Eligibility criteria

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.

Where this trial is running

Koriyama-shi, Fukushima, Fukushima, Japan and 79 other locations

• Seino Internal Medicine Clinic_Internal medicine — Koriyama-shi, Fukushima, Fukushima, Japan, Japan (Recruiting)
• Jinnouchi Hospital_Internal Medicine — Kumamoto, Kumamoto, Japan, Japan (Recruiting)
• Abe Diabetes Clinic_Internal Medicine — Ōita, Oita, Japan, Japan (Enrolling_by_invitation)
• Miyachi Clinic — Aichi, Japan (Recruiting)
• Clinic Tosaki — Aichi, Japan (Recruiting)
• Fukuoka Naika Clinic_Internal Medicine — Aichi, Japan (Enrolling_by_invitation)
• Uenishi Internal Medicine Clinic — Aichi, Japan (Recruiting)
• Ichinomiyanishi Hospital — Aichi, Japan (Enrolling_by_invitation)
• Ohisama Clinic_Aomori — Aomori, Japan (Enrolling_by_invitation)
• Kakizaki Tonyobyo Naika Clinic — Aomori, Japan (Recruiting)
• Chiba Central Medical Center — Chiba, Japan (Enrolling_by_invitation)
• Shinmatsudo Central General Hospital_Diabetes and Endocrinology — Chiba, Japan (Enrolling_by_invitation)
• Kimitsu Chuo Hospital_Diabetology and Endocrinology — Chiba, Japan (Recruiting)
• Soyokaze CardioVascular Medicine and Diabetes Care — Ehime, Japan (Enrolling_by_invitation)
• Kyushu Rosai Hospital_Diabetes and Metabolism — Fukuoka, Japan (Enrolling_by_invitation)
• Kitakyushu Municipal Medical Center_Endocrinology and Diabetes — Fukuoka, Japan (Enrolling_by_invitation)
• Steel Memorial Yawata Hospital_Diabetes Internal Medicine — Fukuoka, Japan (Enrolling_by_invitation)
• Okada Naika Clinic — Fukuoka, Japan (Enrolling_by_invitation)
• Clinic Masae Minami — Fukuoka, Japan (Recruiting)
• Ito Naika Clinic_Internal Medicine — Fukuoka, Japan (Recruiting)
• Gifu University Hospital_Diabetes and Endocrinology — Gifu, Japan (Enrolling_by_invitation)
• Shimizu Naika — Gunma, Japan (Enrolling_by_invitation)
• Takasawa Diabetes Clinic — Hokkaido, Japan (Enrolling_by_invitation)
• Ito Hiroshi Naika Tonyobyonaika Clinic — Hokkaido, Japan (Enrolling_by_invitation)
• Takabe Diabetes Clinic — Hyogogoken, Japan (Enrolling_by_invitation)
• Kagayaki Diabetes and Endocrinology Clinic Sannomiya_Diabetes Internal Medicine — Hyōgo, Japan (Enrolling_by_invitation)
• Matsuda Diabetes Clinic — Hyōgo, Japan (Recruiting)
• Hyogo Prefectural Awaji Medical Center_Diabetes and Endocrinology — Hyōgo, Japan (Enrolling_by_invitation)
• Ushiku Aiwa General Hospital_Diabetes and Metabolism — Ibaraki, Japan (Enrolling_by_invitation)
• Mitoyo General Hospital_Internal Medicine — Kagawa, Japan (Enrolling_by_invitation)
• Tempozan Clinic of Internal Medicine — Kagoshima-shi, Kagoshima, Japan (Enrolling_by_invitation)
• Teikyo Univ.HP, Mizonokuchi_Fourth Internal Medicine — Kanagawa, Japan (Enrolling_by_invitation)
• Yokohama Rosai Hospital_Diabetes and Endocrinology — Kanagawa, Japan (Enrolling_by_invitation)
• Hiyoshi Clinic_Diabetes Internal Medicine — Kanagawa, Japan (Enrolling_by_invitation)
• H.E.C Science Clinic — Kanagawa, Japan (Enrolling_by_invitation)
• Kikuchi Naika Clinic_Kanagawa — Kanagawa, Japan (Recruiting)
• Hotaruno hakuyukai Medical Corporation of Japan — Kisarazu-shi, Chiba, Japan (Recruiting)
• Kumamoto University Hospital, Diabetes, Metabo and Endo — Kumamoto-shi, Kumamoto, Japan (Enrolling_by_invitation)
• Kamiuchi Naika Clinic — Kyoto, Japan (Enrolling_by_invitation)
• Kyoto University Hospital_Department of Diabetes, Endocr — Kyoto-shi, Kyoto, Japan (Enrolling_by_invitation)
• MG Clinic — Mie, Japan (Enrolling_by_invitation)
• Kanno Naika_Internal Medicine — Mitaka-shi, Tokyo, Japan (Recruiting)
• Heiwadai Hospital_Diabetes and Internal Medicine — Miyazaki, Japan (Enrolling_by_invitation)
• Asama General Hospital_Diabetology — Nagano, Japan (Enrolling_by_invitation)
• Minamiminowa Clinic_Internal Medicine and Endocrinology and Metabolism — Nagano, Japan (Enrolling_by_invitation)
• Sasebo City General Hospital_Diabetes and Endocrinology — Nagasaki, Japan (Enrolling_by_invitation)
• Kuriya Clinic_Diabetes and Internal Medicine — Nagasaki, Japan (Enrolling_by_invitation)
• Minagawa Clinic Internal Medicine — Niigata, Japan (Enrolling_by_invitation)
• Kitakamiekimae Naika Clinic — Numakunai, Japan (Recruiting)
• Okayama Medical Center_Diabetes and Endocrinology — Okayama, Japan (Enrolling_by_invitation)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Diabetes Mellitus, Type 1