Suspended

LixiLan-DSoliqua™100/33 vs Lantus® for Type 2 Diabetes Mellitus in Diverse Patients Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

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Study Aim

This study aims to compare the effectiveness of Soliqua™100/33 and Lantus® in managing Type 2 Diabetes Mellitus in diverse patients who are not adequately controlled with basal insulin and oral antidiabetic agents, by observing the change in Glycated Hemoglobin (HbA1c) levels from the beginning to the 26th week.

What is being tested

Insulin glargine/Lixisenatide

+ Background therapy

+ Insulin glargine (HOE901)

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2018
See protocol details

Summary

Principal SponsorSanofi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 20, 2018

Actual date on which the first participant was enrolled.

This study focuses on comparing the effectiveness and safety of two diabetes treatments, Soliqua™100/33 and Lantus®, in ethnically and racially diverse patients with Type 2 Diabetes Mellitus. These patients have not been able to control their diabetes adequately with basal insulin and oral antidiabetic medications. The research aims to find a better treatment option for this group of patients, potentially improving their diabetes management and overall health. The study lasts for about 29 weeks, including a 2-week screening period, a 26-week treatment period, and a 3-day follow-up period. During the treatment period, participants receive either Soliqua™100/33 or Lantus®. The main outcome measured is the change in glycated hemoglobin (HbA1c) levels from the start to the end of the 26-week treatment period. This change is calculated by subtracting the baseline HbA1c value from the value at week 26, indicating how well the treatments control blood sugar levels.

Official TitleA 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
NCT03434119
Principal SponsorSanofi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

241 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 85 locations

Suspended

Investigational Site Number 8400072

Montgomery, United StatesOpen Investigational Site Number 8400072 in Google Maps
Suspended

Investigational Site Number 8400077

Little Rock, United States
Suspended

Investigational Site Number 8400095

Little Rock, United States
Suspended

Investigational Site Number 8400013

Little Rock, United States
Suspended85 Study Centers