Unknown

Dataset Information

0

Efficacy and safety of LY2963016 insulin glargine versus insulin glargine (Lantus) in Chinese adults with type 2 diabetes: A phase III, randomized, open-label, controlled trial.


ABSTRACT:

Aim

To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) with insulin glargine (Lantus; IGlar) combined with oral antihyperglycaemic medications (OAMs) in insulin-naive Chinese patients with type 2 diabetes (T2D).

Materials and methods

In this phase III, open-label trial, adult patients with T2D receiving two or more OAMs at stable doses for 12 weeks or longer, with HbA1c of 7.0% or more and 11.0% or less, were randomized (2:1) to receive once-daily LY IGlar or IGlar for 24 weeks. The primary outcome was non-inferiority of LY IGlar to IGlar at a 0.4% margin, and a gated secondary endpoint tested non-inferiority of IGlar to LY IGlar (-0.4% margin), assessed by least squares (LS) mean change in HbA1c from baseline to 24 weeks.

Results

Patients assigned to LY IGlar (n = 359) and IGlar (n = 177) achieved similar and significant reductions (p < .001) in HbA1c from baseline. LY IGlar was non-inferior to IGlar for change in HbA1c from baseline to week 24 (-1.27% vs. -1.23%; LS mean difference: -0.05% [95% CI, -0.19% to 0.10%]) and IGlar was non-inferior to LY IGlar. The study therefore showed equivalence of LY IGlar and IGlar for the primary endpoint. At week 24, there were no between-group differences in the proportion of patients achieving an HbA1c of less than 7.0%, seven-point self-measured blood glucose, insulin dose or weight gain. Adverse events, allergic reactions, hypoglycaemia and insulin antibodies were similar in the two groups.

Conclusions

Once-daily LY IGlar and IGlar, combined with OAMs, provide effective and similar glycaemic control with comparable safety profiles in insulin-naive Chinese patients with T2D.

SUBMITTER: Feng W 

PROVIDER: S-EPMC8361736 | biostudies-literature |

REPOSITORIES: biostudies-literature

Similar Datasets

| S-EPMC9314964 | biostudies-literature
| S-EPMC5215447 | biostudies-literature
| S-EPMC4737399 | biostudies-literature
| S-EPMC5446380 | biostudies-literature
| S-EPMC5067552 | biostudies-literature
| S-EPMC8323172 | biostudies-literature
| S-EPMC6617768 | biostudies-literature
| S-EPMC6349279 | biostudies-literature
| S-EPMC6585712 | biostudies-literature
| S-EPMC5941245 | biostudies-literature