Type 2 diabetes (T2D)
Conditions
Brief summary
Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = %-point
Detailed description
Relative change in body weight from baseline (week 0) to end of treatment (week 40); unit = %, Change in body weight from baseline (week 0) to end of treatment (week 40); unit = kg, Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = %-point, Change in HbA1c from baseline (week 0) to end of treatment (week 40); unit = %-point, Change in HOMA2-IR from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in HOMA2-B from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in fasting plasma glucose (FPG) from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = mmol/L, CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL) from baseline (week -2 to week 0) to week 14-16, week 26-28 and week 38-40, respectively; unit = %-points, Relative change in body weight from baseline (week 0) to end of treatment (week 40); unit = %, Change in body weight from baseline (week 0) to end of treatment (week 40); unit = kg, Change in body mass index (BMI) from baseline (week 0) to end of treatment (week 40); unit = kg/m2, Change in waist circumference from baseline (week 0) to end of treatment (week 40); unit = cm, Change in waist-to-height ratio (WHtR) from baseline (week 0) to end of treatment (week 40); no unit, Change in systolic blood pressure (SBP) from baseline (week 0) to end of treatment (week 40); unit = mmHg, Change in diastolic blood pressure (DBP) from baseline (week 0) to end of treatment (week 40); unit = mmHg, Change in pulse rate from baseline (week 0) to end of treatment (week 40); unit = beats/min, Change in high sensitivity C-Reactive Protein (hsCRP) from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in total cholesterol from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in high-density lipoprotein (HDL) cholesterol from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in low-density lipoprotein (LDL) cholesterol from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in triglycerides from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in urine albumincreatinine ratio (UACR) from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40) ; unit = Ratio to baseline, Change in eGFR (creatininecystatin C-based CKD-EPI 2021) from baseline (week 0) to end of treatment (week 40); unit = mL/min/1.73 m2
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = %-point | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative change in body weight from baseline (week 0) to end of treatment (week 40); unit = %, Change in body weight from baseline (week 0) to end of treatment (week 40); unit = kg, Change in HbA1c from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = %-point, Change in HbA1c from baseline (week 0) to end of treatment (week 40); unit = %-point, Change in HOMA2-IR from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in HOMA2-B from baseline (week 0) to end of treatment (week 40); unit = Ratio to baseline, Change in fasting plasma glucose (FPG) from baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40); unit = mmol/L, CGM: Change in time in range (TIR) 3.9–10.0 mmol/L (70–180 mg/dL) from baseline (week -2 to week 0) to week 14-16, week 26-28 and week 38-40, respectively; unit = %-points, Relative change in body weight from baseline (week 0) to end of treatment (week 40); unit = %, Change in | — |