Outcome and baseline measures
diabetes, co-morbidities, Diabetes
DIABETES, SECONDARY, DIABETES
The primary outcome measure was HbA1c after each 16-week treatment period. The primary analysis was to test stratification in HbA1c response by Māori or Pacific ethnicity and the pre-specific secondary analysis was to test stratification in HbA1c response by OHTG status. To minimise confounding by adherence or treatment change, protocol adherence was considered to be those who on assessment had >75% adherence to the trial medication based on pill counts, had not commenced any additional glucose-lowering therapies since the baseline eligibility visit, and had not stopped any baseline glucose-lowering medication. HbA1c data were considered invalid if they were obtained more than 7 days after completing the study medication phase. Secondary outcome measures included body weight, blood pressure (BP), frequency of side effects, and Diabetes Treatment Satisfaction Questionnaire (DTSQ) (Self-reported ethnicity was recorded at the baseline visit. Participants were asked to tick all of the following categories that applied: Māori, Pacific, NZ European, Other European, Indian, Other Asian, Other (asked to specify). Prioritised ethnicity classification as Māori or Pacific was defined if either of these ethnicities were ticked or specified in “Other”. Diabetes diagnosis date, current and past diabetes medications, co-morbidities and other medications were verified by medical records. Fasting blood tests were performed to assess HbA1c, glucose, lipids, renal, liver function at baseline and were repeated at the end of each treatment period. OHTG was defined by the presence of BMI ≥30kg/m