Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in type 2 diabetes: study protocol for a randomized controlled trial

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

T2DM, type 2 diabetes mellitus; MAGE, mean amplitude of glycemic excursion; CGMS, continuous glucose monitoring system; BMI, body mass index; WC, waist circumference; MCP-1, monocyte chemotactic protein-1; hs-CRP, high-sensitivity C-reactive protein

ISSN: 1745-6215