efficacy and safety of soliqua versus lantus in ethnically/racially diverse patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic agents

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: * to demonstrate the superiority of soliqua 100/33 versus lantus in the hemoglobin a1c (hba1c) change within the overall population. * to demonstrate the benefit of soliqua 100/33 versus lantus in the hba1c within each ethnic/racial subgroup evaluated (ie, hispanics of any race, non-hispanic black/african americans and non-hispanic asians). secondary objective: * to assess the effects of soliqua 100/33 versus lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated. * to assess the change in daily insulin glargine dose within each ethnic/racial subgroup. * to evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of soliqua 100/33 versus lantus within each ethnic/racial subgroup.

the study duration was approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days follow-up period.

Eligibility criteria:
inclusion criteria : * participants with type 2 diabetes mellitus (t2dm) diagnosed at least 1 year prior to the screening visit (signing of informed consent). * uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin a1c (hba1c) between 7.5% and 10% (inclusive). * participants who were hispanics of any race, non-hispanic black/african americans or non-hispanic asians. note: decision for ethnic/racial inclusion was made based on the participant's self-identification. mixed-race participants must select 1 of the above-mentioned categories. if such selection could not be made, the candidate would be ineligible to participate in the study. * participants who had been treated with any basal insulin (ie, glargine - u100 or u300, detemir, degludec, intermediate-acting \[human neutral protamine hagedorn (nph\]) for at least 6 months prior to visit 1. * the basal insulin regimen (ie, type of insulin and time/frequency of the injection) had been stable for at least 3 months prior to visit 1. * the basal insulin dose had been stable (defined as up to ±20% \[1/5 of the dose\] variability) for at least 2 months prior to visit 1 within the following dose ranges: * 15 to 50 units/day if hba1c at visit 1 is less than or equal to (\<=)8.5%, and * 15 to 40 units/day if hba1c at visit 1 is greater than (\>)8.5%. * participants receiving 1 or 2 of the following oad drugs: metformin, pioglitazone/rosiglitazone, an sodium-glucose transport protein 2 (sglt-2) inhibitor or a sulfonylurea (su), at stable doses for at least 12 weeks prior to visit 1. exclusion criteria: * age \<18 years of age at visit 1. * a body mass index (bmi) \ 40 kg/m\^2 at visit 1. * fasting plasma glucose (fpg) \>200 mg/dl (by central lab measurement) at visit 1 (1-time repeat measurement before visit 2 is permitted). * type 1 dm or any diabetes other than t2dm. * any use of oad drugs other than those described in the inclusion criteria (e.g., but not limited to, glucagon like peptide-1 receptor agonist (glp-1 ra), dipeptidyl peptidase 4 (dpp4) inhibitors) within 12 weeks prior visit 1. * use of any other type of insulin except for basal insulin (e.g., prandial or premixed insulin, insulin pump) within 6 months prior to visit 1. note: history of short-term treatment (i.e, \<=10 days) with other insulin types due to intercurrent illness was permitted at the discretion of the investigator. * known history of discontinuation of treatment with a glp-1 ra due to safety/tolerability reasons. * use of systemic glucocorticoids for a total duration of \>7 days within 12 weeks prior to visit 1. * initiation/change in type or dose of a weight loss drug within 12 weeks prior to visit 1. the above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.