Background: We have previously demonstrated least glucose variability, hypoglycemia as well as the best time in range on continuous glucose monitoring (CGM) for the basal insulin with GLP-1 RA combination among four commonly prescribed insulin regimen in a population with T2D with various ethnic backgrounds. 
Aims: VARIATION 2 SA is the first head-to-head trial comparing a fixed-ratio combination of glargine-GLP1 RA (iGlarLixi) to the traditional approach of initiating insulin glargine together with a sulfonylurea, both added to metformin, performed exclusively in South Asian origin subjects. 
Methods: VARIATION 2 SA is a 16-week randomized, pragmatic, multi-center trial (ClinicalTrials.gov Identifier: NCT03819790). The trial is enrolling patients of South Asian origin not meeting targets (inclusion criteria HbA1c: 7.1-11%) with oral hypoglycemic agents.  Subjects are randomized 1:1 to insulin glargine + gliclazide MR 60 mg OD + metformin vs. a regimen of iGlarLixi + metformin, after a one week run-in phase with insulin glargine. Baseline CGM parameters are obtained during run-in before randomization. Co-primary outcomes are average percentage of Time-in-range (TIR, 4.0-10.0 mmol/L) within 12-hour (6 AM -6 PM) and 24-hour periods on 7-day CGM performed at the end of the trial. Secondary outcomes include measures of glucose variability and hypoglycemia, patient-reported outcomes and assessment of differences in outcomes by carbohydrate intake.
Results:  No significant differences for %TIR, hypoglycemia and hyperglycemia between glargine + gliclazide MR and iGlarLixi groups (n=24) were found within 12-hr or 24-hr period. No significant differences were found for body mass index, HbA1c and insulin dose at week 13 between groups.

Randomized comparison of initiating insulin glargine or iGlarLixi in South Asian subjects with T2D: VARIATION 2 SA trial