Outcomes
deaths, strokes, Triglycerides reduced
ADVERSE EVENTS, MYOCARDIAL INFARCTION, STROKES
Overall, a greater mean decrease in HbA1c was observed after pioglitazone than after vildagliptin treatment (adjusted mean difference -4.9mmol/mol [-0.5%], 95%CI -6.3, -3.5; p < 0.0001) (The estimated medication effects on HbA1c and its interaction with ethnicity (primary outcome analysis).ITT, intention to treat; PP, per protocol; CI, confidence interval.The estimated medication effects on patient outcomes and its interaction with patient groups.All valid patient data collected at baseline and after each medication treatment were used in the analysis; missing data were not imputed.*Questions contained in the DTSQ are shown in A treatment difference in HbA1c response was observed in participants with OHTG (-5.9mmol/mol [0.54%]) compared with those without OHTG (-1.2mmol/mol [0.11%]), with an estimated interaction effect of -4.7mmol/mol [0.43%], 95%CI -8.1, -1.4, p=0.005 (Mean weight after pioglitazone was higher than after vildagliptin treatment, with an adjusted mean difference of 1.6kg (95%CI [1.1, 2.0]; p<0.0001). There was no interaction in weight change response to pioglitazone versus vildagliptin by ethnicity or OHTG status (DTSQ scores at baseline and after each treatment.*Derived from the sum of responses to question 1 and questions 4-8 each rated on a scale from 0 to 6, with a high score (maximum 36) representing high treatment satisfaction.Hepatic enzymes, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) were lower after pioglitazone but remained unchanged after vildagliptin (difference p<0.0001). The difference in hepatic enzymes after pioglitazone vs vildagliptin, did not differ significantly by Māori and Pacific ethnicity or OHTG. Triglycerides reduced after pioglitazone compared with after vildagliptin (mean difference -0.3mmol/L, p<0.0001), with no interaction by ethnicity or OHTG grouping. HDL-C increased more after pioglitazone than after vildagliptin (+0.1mmol/L, p<0.0001).At the final trial visit, 257 participants indicated their preferred medication: 98 (38%) preferred pioglitazone, 87 (34%) preferred vildagliptin, and 72 (28%) indicated either no preference (n=62) or neither (n=10). No differences in medication preference were found by ethnicity, or OHTG strata after adjusting for their treatment sequence (PV or VP), the change in HbA1c, weight and DTSQ score between two treatments.There were 15 serious adverse events: 3 deaths (2 strokes and 1 myocardial infarction) and 12 hospitalisations. None were deemed to be due to the trial medication by an independent data safety monitoring committee.