LixiLan-D

TerminatedPhase 3Results posted

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

A 26-week Randomized, Open-label, Active-controlled, 2-treatment Arm, Parallel Group Multi-center Study, Comparing the Efficacy and Safety of Soliqua™100/33 Versus Lantus® in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

241

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-10%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03434119

Org study IDLPS14860

Secondary IDU1111-1200-1891UTN

Timeline

Milestones

Study first posted2018-02-15actual

Study start2018-02-20actual

Primary completion2019-01-07actual

Study completion2019-01-07actual

Results first posted2020-01-13actual

Last update posted2022-03-28actual

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilograms (kg)	95% CI
Soliqua 100/33	1.69	—
Lantus	1.52	—

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of HbA1c	95% CI
Soliqua 100/33	-1.86	—
Lantus	-1.07	—

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Target of <7% at Week 26

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Soliqua 100/33	52.6	—
Lantus	30.8	—

Secondary/protocol endpoint

Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Daily Insulin Glargine Dose at Week 26

Time frame:Baseline, Week 26

change from baseline, descriptive

Posted result

Group	Value (mean), International Units (IU)	95% CI
Soliqua 100/33	18.7	—
Lantus	14.1	—

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period

Time frame:Baseline to Week 26

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), percentage of participants	95% CI
Soliqua 100/33Any hypoglycemia	48.7	—
Severe hypoglycemia	1.7	—
Documented hypoglycaemia <=70 mg/dL (3.9 mmol/L)	43.5	—
Documented hypoglycaemia <54 mg/dL (3.0 mmol/L)	12.2	—
LantusAny hypoglycemia	52.8	—
Severe hypoglycemia	2.4	—
Documented hypoglycaemia <=70 mg/dL (3.9 mmol/L)	48.8	—
Documented hypoglycaemia <54 mg/dL (3.0 mmol/L)	18.4	—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.