Table 2 Primary and secondary outcomes
Outcome measure: | |
|---|---|
Primary outcome | |
To compare the effect of exenatide versus biphasic insulin aspart 30 on glucose variability in T2DM patients inadequately controlled with metformin monotherapy. | Absolute change of MAGE from baseline to Week 16 |
Secondary outcome | |
To compare the effect of exenatide versus biphasic insulin aspart 30 on inflammatory and oxidative stress markers, HbA1c, weight, risk of hypoglycemia and cardiovascular risk markers. | HbA1c at baseline and Week 16 |
Hours of hypoglycemia assessing by CGMS at baseline and Week 16 | |
SMBG at baseline and Week 16 | |
Blood pressure and lipids at baseline and Week 16 | |
Body weight, BMI and WC at baseline and Week 16 | |
Inflammatory markers (MCP-1, hs-CRP) at baseline and Week 16 | |
Urinary albumin at baseline and Week 16 | |
Safety outcome | |
To evaluate the safety and tolerability of exenatide in relation to biphasic insulin aspart 30. | Adverse events/serious adverse events |
Vital signs | |
Clinical hypoglycemia | |
Collection of clinical chemistry/hematology parameters | |
Electrocardiogram | |