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®.
Study Type
OBSERVATIONAL
Enrollment
3,217
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.
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, Japan
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, Japan
Takai Internal Medicine Clinic_Internal Medicine
Kamakura-shi, Kanagawa, Kanagawa, Japan, Japan
Matsuba Clinic_Internal Medicine
Kawasaki-shi, Kanagawa, Japan, Japan
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, Japan
Number of adverse events (AEs)
Count
Time frame: From baseline (day 0) to end of study (month 36)
Number of serious adverse reactions (SARs)
Count
Time frame: From baseline (day 0) to end of study (month 36)
Number of adverse reactions (ARs)
Count
Time frame: From baseline (day 0) to end of study (month 36)
Number of serious adverse events (SAEs)
Count
Time frame: From baseline (day 0) to end of study (month 36)
Change in glycosylated haemoglobin A1c (HbA1c)
Percent
Time frame: From baseline (day 0) to end of study (month 36)
Change in fasting plasma glucose (FPG)
mg/dL
Time frame: From baseline (day 0) to end of study (month 36)
Change in body weight
kg
Time frame: From baseline (day 0) to end of study (month 36)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score
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)
Time frame: From baseline (day 0) to visit 5 (month 12)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities
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)
Time frame: From baseline (day 0) to visit 5 (month 12)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment
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)
Time frame: From baseline (day 0) to visit 5 (month 12)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia
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)
Time frame: From baseline (day 0) to visit 5 (month 12)
Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment
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)
Time frame: From baseline (day 0) to visit 5 (month 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
Abe Diabetes Clinic_Internal Medicine
Ōita, Oita, Japan, Japan
Iryo Houjin Hakuunkai Ryoya Komatsu Clinic,Internal medicine
Izumisano, Osaka, Japan, Japan
Asano Clinic
Kawagoe-shi, Saitama, Japan, Japan
Tokyo Saiseikai Central Hospitl, Internal Med
Minatoku, Tokyo, Japan, Japan
...and 404 more locations