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 (LixiLan-D)

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Status and phase

Phase 3


Type 2 Diabetes Mellitus


Drug: Background therapy
Drug: Insulin glargine/Lixisenatide
Drug: Insulin glargine (HOE901)

Study type


Funder types



U1111-1200-1891 (Other Identifier)

Details and patient eligibility


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.

Full description

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.


241 patients




18+ years old


No Healthy Volunteers

Inclusion and exclusion 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) <=20 or >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.

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

241 participants in 2 patient groups

Soliqua 100/33
Experimental group
Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.
Drug: Insulin glargine/Lixisenatide
Drug: Background therapy
Active Comparator group
Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Drug: Insulin glargine (HOE901)
Drug: Background therapy

Trial documents

Trial contacts and locations



Data sourced from clinicaltrials.gov

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