Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial.

ABSTRACT:

Objective

To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).

Research design and methods

In this phase 3, open-label, multicenter trial, 321 patients with HbA_1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA_1c at week 26.

Results

Change in HbA_1c from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confir

SUBMITTER: Watada H 

PROVIDER: S-EPMC7245357 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature