A prospective, multicentre, randomized, open-label comparison of a long-acting basal insulin analog glargine plus glulisine with premixed insulin in insulin naïve patients with Type 2 diabetes - A study from India.

AIMS: We aimed to compare the effectiveness of Glargine plus Glulisine to premixed insulin analogue, as measured by HbA1c ≤ 7.0% in insulin naive Type 2 Diabetes (T2D) patients with elevated fasting and/or postprandial plasma glucose.

METHODS: Insulin-naive T2D patients (116 men, 84 women) on ≥ 2 oral hypoglycemic agents with inadequate glycemic control were randomized either to group 1 (insulin Glargine plus Glulisine, n = 101) or group 2 (Premixed Insulin analogue, n = 99).

RESULTS: In the intention to treat analysis, at week 24, percentage of patients with good glycaemic control (HbA1c ≤ 7.0%) was similar between the two groups (16.8% in Group 1 vs. 13.1% in Group 2, χ2 - 0.535, p = 0.47). Significant reductions in fasting and postprandial levels were observed in groups 1 and 2 at both post-baseline time points (Week 12 and 24). In group 1, reduction in HbA1c from baseline to week 12 was 0.6 ± 0.1 and 0.7 ± 0.2 at week 24, p < 0.0001 for all. In group 2, no significant change in HbA1c was observed. In group 1, 83.2% required an additional dose of glulisine and in group 2, 88.9% required an additional dose of premixed insulin. Hypoglycemic events were similar in both groups (0.12 events per person-year in group 1 and 0.13 events per person-year in group 2). Weight gain was non-significant in both groups.

CONCLUSIONS: Glargine plus Glulisine, though in higher dose was effective as premixed insulin in lowering HbA1c. Hypoglycemic events per person-year were similar in both groups.