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NCT Number: NCT06807190

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

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.

Recruiting

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Seino Internal Medicine Clinic_Internal medicine, Koriyama-shi, Fukushima, Fukushima, Japan, Japan

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin icodec

Drug

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

Other names: Awiqli

Primary outcomes

  1. Number of Adverse Reactions (ARs)

    Time frame: From baseline (week 0) to end of study (week 52)

    Measured as number of events.

Secondary outcomes

  1. Number of Adverse Events (AEs)

    Time frame: From baseline (week 0) to end of study (week 52)

    Measured as number of events.

  2. Number of Serious Adverse Events (SAEs)

    Time frame: From baseline (week 0) to end of study (week 52)

    Measured as number of events.

  3. Number of Serious Adverse Reactions (SARs)

    Time frame: From baseline (week 0) to end of study (week 52)

    Measured as number of events.

  4. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of study (week 52)

    Measured as percentage (%) point of HbA1c.

  5. Change in Fasting Plasma Glucose (FPG)

    Time frame: From baseline (week 0) to end of study (week 52)

    Measured as milligrams per decilitre (mg/dL).

  6. Change in Diabetes Therapy-Related Quality Of Life (DTR-QOL)

    Time frame: From baseline (week 0) to end of study (week 52)

    DTR-QOL is a Japanese questionnaire assessing the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 questions and the response scale is a 7-point scale (1: strongly agree to 7: strongly disagree). The score of each item will be reversed so that "7: strongly disagree" represents the highest/desirable QOL. The total score, after simple addition of the item scores, is converted to 0 to 100 (best-case response is 100; worst case response is 0).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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