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NCT Number: NCT04469855

Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®

The purpose of this study is to assess the safety of long-term treatment with Ozempic® in patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their doctor. People will be in this study about 3 years. People above the age of 18 will be asked to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the assessment of the influence of diabetes treatment on people's life). There is a possibility that people's blood sample would be provided to Novo Nordisk from their doctors in case of severe allergic reaction that might be caused by Ozempic®.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders 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

Healthy volunteers accepted: No

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 Ozempic® 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.
  • Patients with Diabetes Mellitus, Type 2 (T2DM) who the physician has decided to start treatment with Ozempic®.
  • Male or female, no age limitation.

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Patients who fall under contraindications to the label.
  • Patients who are or have previously been treated with Ozempic®.
  • Female who is pregnant, breast-feeding or intends to become pregnant.

Treatment and study plan

semaglutide

Drug

Patients will be treated with commercially available Ozempic® according to routine clinical practice at the discretion of the treating physician. The treating physician's decision to initiate treatment with Ozempic® is independent of the decision to include the patient in the study.

Primary outcomes

  1. Number of adverse events (AEs)

    Time frame: From baseline (day 0) to end of study (month 36)

    Count

Secondary outcomes

  1. Number of serious adverse reactions (SARs)

    Time frame: From baseline (day 0) to end of study (month 36)

    Count

  2. Number of adverse reactions (ARs)

    Time frame: From baseline (day 0) to end of study (month 36)

    Count

  3. Number of serious adverse events (SAEs)

    Time frame: From baseline (day 0) to end of study (month 36)

    Count

  4. Change in glycosylated haemoglobin A1c (HbA1c)

    Time frame: From baseline (day 0) to end of study (month 36)

    Percent

  5. Change in fasting plasma glucose (FPG)

    Time frame: From baseline (day 0) to end of study (month 36)

    mg/dL

  6. Change in body weight

    Time frame: From baseline (day 0) to end of study (month 36)

    kg

  7. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score

    Time frame: From baseline (day 0) to visit 5 (month 12)

    DTR-QOL assesses 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 items. The response scale used is a 7-point Likert scale (1:

    Strongly agree - 7: Strongly disagree)

  8. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities

    Time frame: From baseline (day 0) to visit 5 (month 12)

    DTR-QOL assesses 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 items. The response scale used is a 7-point Likert scale (1:

    Strongly agree - 7: Strongly disagree)

  9. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment

    Time frame: From baseline (day 0) to visit 5 (month 12)

    DTR-QOL assesses 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 items. The response scale used is a 7-point Likert scale (1:

    Strongly agree - 7: Strongly disagree)

  10. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia

    Time frame: From baseline (day 0) to visit 5 (month 12)

    DTR-QOL assesses 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 items. The response scale used is a 7-point Likert scale (1:

    Strongly agree - 7: Strongly disagree)

  11. Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment

    Time frame: From baseline (day 0) to visit 5 (month 12)

    DTR-QOL assesses 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 items. The response scale used is a 7-point Likert scale (1:

    Strongly agree - 7: Strongly disagree)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®. A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Ozempic® (Semaglutide) in Japanese Patients With Type 2 Diabetes Mellitus Under Normal Clinical Practice Condition

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2020
Registry last updated
May 19, 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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