Type 2 diabetes mellitus (T2DM)
Conditions
Brief summary
Change from Baseline in HbA1c at Week 24 of the Treatment
Detailed description
Change from Baseline in HbA1c at Week 12 of the Treatment, Change from Baseline in fasting plasma glucose (FPG) at Week 12 and 24 of the Treatment, Proportion (%) of subjects who achieved HbA1c < 6.5% at Week 24 of the Treatment, Proportion (%) of subjects who achieved HbA1c < 7.0% at Week 24 of the Treatment, Change from Baseline in lipid profile (total cholesterol, LDL-C, HDL-C, and TG) levels at Week 12 and 24 of the Treatment, Change from Baseline in insulin resistance (HOMA-IR) and insulin secretion ability (HOMA-β) at Week 12 and 24 of the Treatment, Change from Baseline in liver function indicators (AST, ALT) at Week 12 and 24 of the Treatment, Proportion (%) of subjects who received a rescue medication at Week 12 and 24 of the Treatment, Change from Baseline in body weight at Week 12 and 24 of the Treatment, Change from Baseline in blood pressure (SBP, DBP) at Week 12 and 24 of the Treatment, Change from Baseline in heart rate at Week 12 and 24 of the Treatment, Change from Baseline in waist circumference at Week 12 and 24 of the Treatment
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c at Week 24 of the Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c at Week 12 of the Treatment, Change from Baseline in fasting plasma glucose (FPG) at Week 12 and 24 of the Treatment, Proportion (%) of subjects who achieved HbA1c < 6.5% at Week 24 of the Treatment, Proportion (%) of subjects who achieved HbA1c < 7.0% at Week 24 of the Treatment, Change from Baseline in lipid profile (total cholesterol, LDL-C, HDL-C, and TG) levels at Week 12 and 24 of the Treatment, Change from Baseline in insulin resistance (HOMA-IR) and insulin secretion ability (HOMA-β) at Week 12 and 24 of the Treatment, Change from Baseline in liver function indicators (AST, ALT) at Week 12 and 24 of the Treatment, Proportion (%) of subjects who received a rescue medication at Week 12 and 24 of the Treatment, Change from Baseline in body weight at Week 12 and 24 of the Treatment, Change from Baseline in blood pressure (SBP, DBP) at Week 12 and 24 of the Treatment, Change from Baseline in heart rate at Week 12 and 24 of the Treatment, Change from Bas | — |
Countries
Poland