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)

March 21, 2022 updated by: Sanofi

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Investigational Site Number 8400072
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Investigational Site Number 8400077
      • Little Rock, Arkansas, United States, 72205
        • Investigational Site Number 8400095
      • Little Rock, Arkansas, United States, 72211
        • Investigational Site Number 8400013
    • California
      • Anaheim, California, United States, 92801-4123
        • Investigational Site Number 8400076
      • Anaheim, California, United States, 92801
        • Investigational Site Number 8400052
      • Anaheim, California, United States, 92805
        • Investigational Site Number 8400069
      • Burbank, California, United States, 91505
        • Investigational Site Number 8400060
      • Cerritos, California, United States, 90703
        • Investigational Site Number 8400049
      • Chula Vista, California, United States, 91910
        • Investigational Site Number 8400078
      • Escondido, California, United States, 92025
        • Investigational Site Number 8400047
      • Fountain Valley, California, United States, 92708
        • Investigational Site Number 8400066
      • Greenbrae, California, United States, 94904
        • Investigational Site Number 8400050
      • Huntington Park, California, United States, 90255
        • Investigational Site Number 8400092
      • Los Angeles, California, United States, 90017
        • Investigational Site Number 8400015
      • Los Angeles, California, United States, 90057
        • Investigational Site Number 8400011
      • Los Angeles, California, United States, 90094
        • Investigational Site Number 8400301
      • Los Angeles, California, United States, 90094
        • Investigational Site Number 8400302
      • Los Angeles, California, United States, 90094
        • Investigational Site Number 8400303
      • Los Angeles, California, United States, 90094
        • Investigational Site Number 8400304
      • Los Gatos, California, United States, 95032
        • Investigational Site Number 8400006
      • Oakland, California, United States, 94612
        • Investigational Site Number 8400048
      • Orange, California, United States, 92868
        • Investigational Site Number 8400053
      • Pomona, California, United States, 91766
        • Investigational Site Number 8400084
      • Pomona, California, United States, 91767
        • Investigational Site Number 8400081
      • Rancho Cucamonga, California, United States, 91730
        • Investigational Site Number 8400042
      • San Carlos, California, United States, 94070
        • Investigational Site Number 8400063
      • San Diego, California, United States, 92114
        • Investigational Site Number 8400091
      • San Jose, California, United States, 95148
        • Investigational Site Number 8400086
      • Santa Ana, California, United States, 92701
        • Investigational Site Number 8400074
      • Temecula, California, United States, 92591
        • Investigational Site Number 8400037
      • Vallejo, California, United States, 94592
        • Investigational Site Number 8400087
      • Van Nuys, California, United States, 91405
        • Investigational Site Number 8400024
      • Ventura, California, United States, 93003
        • Investigational Site Number 8400007
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Investigational Site Number 8400054
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Investigational Site Number 8400023
    • Florida
      • Gainesville, Florida, United States, 32653
        • Investigational Site Number 8400041
      • Jacksonville, Florida, United States, 32204
        • Investigational Site Number 8400075
      • Miami, Florida, United States, 33144
        • Investigational Site Number 8400036
      • Miami, Florida, United States, 33176
        • Investigational Site Number 8400017
      • Miami Lakes, Florida, United States, 33014
        • Investigational Site Number 8400016
      • Ocoee, Florida, United States, 34761
        • Investigational Site Number 8400014
      • Port Charlotte, Florida, United States, 33952
        • Investigational Site Number 8400028
      • Saint Petersburg, Florida, United States, 00000
        • Investigational Site Number 8400097
      • Saint Petersburg, Florida, United States, 33713
        • Investigational Site Number 8400035
      • Tampa, Florida, United States, 33634
        • Investigational Site Number 8400094
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Investigational Site Number 8400025
      • Atlanta, Georgia, United States, 30310
        • Investigational Site Number 8400051
      • Atlanta, Georgia, United States, 30318
        • Investigational Site Number 8400093
      • Savannah, Georgia, United States, 31406-2675
        • Investigational Site Number 8400005
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Investigational Site Number 8400038
      • Chicago, Illinois, United States, 60607
        • Investigational Site Number 8400088
      • Des Plaines, Illinois, United States, 60018
        • Investigational Site Number 8400031
      • Evanston, Illinois, United States, 60201
        • Investigational Site Number 8400064
      • Gurnee, Illinois, United States, 60031
        • Investigational Site Number 8400057
    • Louisiana
      • Gretna, Louisiana, United States, 70053
        • Investigational Site Number 8400030
      • New Orleans, Louisiana, United States, 70124
        • Investigational Site Number 8400009
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Investigational Site Number 8400065
      • Rockville, Maryland, United States, 20852
        • Investigational Site Number 8400061
    • Michigan
      • Chelsea, Michigan, United States, 48118
        • Investigational Site Number 8400079
      • Flint, Michigan, United States, 48504
        • Investigational Site Number 8400001
      • Flint, Michigan, United States, 48532-3447
        • Investigational Site Number 8400012
    • Nevada
      • Las Vegas, Nevada, United States, 89117
        • Investigational Site Number 8400090
      • Las Vegas, Nevada, United States, 89148
        • Investigational Site Number 8400082
    • New Jersey
      • Linden, New Jersey, United States, 07036
        • Investigational Site Number 8400018
    • New York
      • Bronx, New York, United States, 10455
        • Investigational Site Number 8400003
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigational Site Number 8400062
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Investigational Site Number 8400043
    • Texas
      • Dallas, Texas, United States, 75230
        • Investigational Site Number 8400021
      • Fort Worth, Texas, United States, 76132
        • Investigational Site Number 8400040
      • Houston, Texas, United States, 77089
        • Investigational Site Number 8400045
      • Humble, Texas, United States, 77338
        • Investigational Site Number 8400002
      • Kerrville, Texas, United States, 78028
        • Investigational Site Number 8400039
      • Lufkin, Texas, United States, 75904
        • Investigational Site Number 8400096
      • San Antonio, Texas, United States, 78228
        • Investigational Site Number 8400027
      • San Antonio, Texas, United States, 78230
        • Investigational Site Number 8400083
      • Splendora, Texas, United States, 77372
        • Investigational Site Number 8400008
      • Spring, Texas, United States, 77379
        • Investigational Site Number 8400055
      • Sugar Land, Texas, United States, 77478
        • Investigational Site Number 8400070
      • Sugar Land, Texas, United States, 77479
        • Investigational Site Number 8400085
      • Webster, Texas, United States, 77598
        • Investigational Site Number 8400059
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Investigational Site Number 8400044
      • Norfolk, Virginia, United States, 23510
        • Investigational Site Number 8400068
      • Richmond, Virginia, United States, 23219
        • Investigational Site Number 8400033
    • Washington
      • Richland, Washington, United States, 99352
        • Investigational Site Number 8400029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Soliqua 100/33
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
Insulin glargine (100 units per milliliter [U/mL]) and lixisenatide (33 micrograms per milliliter [mcg/mL]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter [mmol/L]) while avoiding hypoglycemia.
Other Names:
  • HOE901/AVE0010
  • Soliqua 100/33
Drug: Background therapy
Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.
ACTIVE_COMPARATOR: Lantus
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: Background therapy
Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.
Drug: Insulin glargine (HOE901)
Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.
Other Names:
  • Lantus
  • HOE901

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
Time Frame: Baseline, Week 26
Change in HbA1c was calculated by subtracting baseline value from Week 26 value.
Baseline, Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving HbA1c Target of <7% at Week 26
Time Frame: Week 26
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Week 26
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26
Time Frame: Baseline, Week 26
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.
Baseline, Week 26
Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26
Time Frame: Baseline, Week 26
Baseline, Week 26
Change From Baseline in Daily Insulin Glargine Dose at Week 26
Time Frame: Baseline, Week 26
Change in daily dose was calculated by subtracting baseline value from Week 26 value.
Baseline, Week 26
Change From Baseline in Body Weight at Week 26
Time Frame: Baseline, Week 26
Change in body weight was calculated by subtracting baseline value from Week 26 value.
Baseline, Week 26
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period
Time Frame: Baseline to Week 26
Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of <=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose <=70 mg/dL (3.9 mmol/L) and excluding plasma glucose <54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of <54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose <54 mg/dL (3.0 mmol/L) regardless of symptoms.
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LPS14860
  • U1111-1200-1891 (OTHER: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

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Locations

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