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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Seino Internal Medicine Clinic_Internal medicine
  Koriyama-shi, Fukushima, Fukushima, Japan, Japan Recruiting
• Jinnouchi Hospital_Internal Medicine
  Kumamoto, Kumamoto, Japan, Japan Recruiting
• Miyachi Clinic
  Aichi, Japan Recruiting
• Clinic Tosaki
  Aichi, Japan Recruiting
• Uenishi Internal Medicine Clinic
  Aichi, Japan Recruiting
• Kakizaki Tonyobyo Naika Clinic
  Aomori, Japan Recruiting

+66 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.