Imtesty,

There are many pre-specified secondary outcome measures in BETonMACE that relate to glucose/insulin control, including HbA1C, fasting glucose and fasting insulin changes over time. They won't directly assess insulin resistance. However, changes in individual values over time will be very informative as to how apabetalone improves glucose control in this diabetic population. Also, ratio of glucose/insulin over time can be used as a surrogate index for insulin sensitivity. The fact that this is already a diabetic population suggests that there is a lot of room for improvement by apabetalone in these parameters.

From the BETonMACE ClinicalTrials.gov page:

Secondary Outcome Measures:

Time to first occurrence of adjudication-confirmed broadly defined MACE [ Time Frame: 120 weeks ]

Broadly defined MACE (major adverse cardiac event) is the occurrence of any of the following: CV death, non-fatal MI, hospitalization for CVD events, or stroke

Group difference in all-cause mortality [ Time Frame: 120 weeks ]

Percent change in apoA-I concentration over time within and between treatment groups [ Time Frame: 120 weeks ]

Percent change in apoB concentration over time within and between treatment groups [ Time Frame: 120 weeks ]

Percent change in LDL-C concentration over time within and between treatment groups [ Time Frame: 120 weeks ]

Percent change in HDL-C concentration over time within and between treatment groups [ Time Frame: 120 weeks ]

Percent change in TG concentration over time within and between treatment groups [ Time Frame: 120 weeks ]

Change in HbA1c over time within and between treatment groups [ Time Frame: 120 weeks ]

Change in fasting glucose over time within and between treatment groups [ Time Frame: 120 weeks ]

Change in fasting insulin over time within and between treatment groups [ Time Frame: 120 weeks ]

Change in alkaline phosphatase (ALP) over time within and between treatment groups [ Time Frame: 120 weeks ]

including isoforms for whole population and quartiles of ALP baseline concentration

Change in kidney function in population [ Time Frame: 120 weeks ]

baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.7m2

Incidence of AEs and Serious AEs within and between treatment groups [ Time Frame: 120 weeks ]

Other Outcome Measures:

Percent change in hsCRP within and between treatment groups [ Time Frame: 120 weeks ]

Percent change in fibrinogen within and between treatment groups [ Time Frame: 120 weeks ]

Transcription (messenger RNA [mRNA]) change in whole blood [ Time Frame: 6 weeks ]

Health Related Quality of Life (HRQOL) as measured using the EQ-5D-5L [ Time Frame: 122 weeks ]