Type 2 Diabetes
Conditions
Brief summary
The study is testing the incidence of MACE and incidence of renal events between Ozempic® users and users with other anti-diabetic medications in T2D patients. This is a retrospective study, and participants had received Ozempic or any other anti-diabetic medications.
Interventions
None listed
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants had at least one prescription for Ozempic® or other interested anti-diabetic medications during the index identification period. * Participants had at least one diagnosis of T2D, and had at least one of the three following T2D clinical evidence any time before or on the index date * Participants had at least 1 all-cause visit record any time after 6 months post-index date. * At least 18 years old at the index date.
Exclusion criteria
* Patients who have used any same anti-diabetic medications as the index treatment within 6 months before index date (e.g., patient prescribed with any Ozempic® during baseline will be excluded if the index drug is a Ozempic®) * Patients with any diagnosis record of type 1 diabetes or gestational diabetes during whole study period. * Patients who were pregnant during the whole study period. * Patients who participated in any clinical trials during the whole study period. * Patients who were diagnosed with medullary thyroid carcinoma or multiple endocrine neoplasia type II (MEN2) during the whole study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to 3P major adverse cardiovascular events | From index date to the first composite 3P MACE (stroke, myocardial infarction, all-cause death) event or censoring event (up to 36 months) | Measured in days. |
| Time to 5P MACE | From index date to the first composite 5P MACE (stroke, myocardial infarction, all-cause death, heart failure hospitalization, coronary revascularization) event or censoring event (up to 36 months) | Measured in days. |
| Time to stroke | From index date to the first stroke event or censoring event (up to 36 months) | Measured in days. |
| Time to myocardial infarction (MI) | From index date to the first MI event or censoring event (up to 36 months) | Measured in days. |
| Time to heart failure (HF) | From index date to the first HF event or censoring event (up to 36 months) | Measured in days. |
| Time to composite renal event | From index date to first composite renal (kidney failure: dialysis/transplantation/eGFR <15, ≥50% eGFR reduction from baseline, or kidney-related/cardiovascular death) or censoring event (up to 36 months) | Measured in days. |
| Time to renal disease-related hospitalization | From index date to the first renal disease-related hospitalization or censoring event (up to 36 months) | Measured in days. |
| Incidence rate of 3P MACE | From index date to the first composite 3P MACE (stroke, myocardial infarction, all-cause death) event or censoring event (up to 36 months) | Measured in Percentage, per 1000 patient year. |
| Incidence rate of 5P MACE | From index date to the first composite 5P MACE (stroke, myocardial infarction, all-cause death, heart failure hospitalization, coronary revascularization) event or censoring event (up to 36 months) | Measured in Percentage, per 1000 patient year. |
| Incidence rate of stroke | From index date to the first stroke event or censoring event (up to 36 months) | Measured in Percentage, per 1000 patient year. |
| Incidence rate of myocardial infarction | From index date to the first MI event or censoring event (up to 36 months) | Measured in Percentage, per 1000 patient year. |
| Incidence rate of heart failure | From index date to the first HF event or censoring event (up to 36 months) | Measured in Percentage, per 1000 patient year. |
| Incidence rate of composite renal event | From index date to first composite renal (kidney failure: dialysis/transplantation/eGFR <15, ≥50% eGFR reduction from baseline, or kidney-related/cardiovascular death) or censoring event (up to 36 months) | Measured in Percentage, per 1000 patient year. |
| Incidence rate of renal disease-related hospitalization | From index date to the first renal disease-related hospitalization or censoring event (up to 36 months) | Measured in Percentage, per 1000 patient year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of days covered (PDC) in 6 months | From index date to Day 180 | Measured in percentage. |
| PDC in 12 months | From index date to Day 360 | Measured in percentage. |
Countries
China
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed