Type 2 Diabetes
Conditions
Brief summary
Change in HbA1c
Detailed description
Relative change in body weight, Change in body weight, Change in fasting plasma glucose (FPG), CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL), Change in body mass index (BMI), Change in waist circumference, Change in systolic blood pressure (SBP), Change in average 24 hour systolic blood pressure (SBP), Change in high sensitivity C-Reactive Protein (hsCRP), Change in total cholesterol, Change in high-density lipoprotein (HDL) cholesterol, Change in low-density lipoprotein (LDL) cholesterol, Change in triglycerides, Number of adverse events, Change in Urinary Albumin/Creatinine Ratio (UACR), Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g), Change in eGFR creatinine-cystatin C based CKD-EPI
Interventions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative change in body weight, Change in body weight, Change in fasting plasma glucose (FPG), CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL), Change in body mass index (BMI), Change in waist circumference, Change in systolic blood pressure (SBP), Change in average 24 hour systolic blood pressure (SBP), Change in high sensitivity C-Reactive Protein (hsCRP), Change in total cholesterol, Change in high-density lipoprotein (HDL) cholesterol, Change in low-density lipoprotein (LDL) cholesterol, Change in triglycerides, Number of adverse events, Change in Urinary Albumin/Creatinine Ratio (UACR), Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g), Change in eGFR creatinine-cystatin C based CKD-EPI | — |
Countries
Bulgaria, Croatia, Germany, Greece, Hungary, Poland, Romania, Slovakia, Spain
Outcome results
None listed