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Type 2 Diabetes MellitusPhase 3LixiLan-DNCT03434119

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 Phase 3 study testing Insulin glargine/Lixisenatide, Insulin glargine (HOE901) and Background therapy in people with Type 2 Diabetes Mellitus, run by Sanofi at 85 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Insulin glargine/Lixisenatide, Insulin glargine (HOE901) and Background therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
85 sitesUnited States
Study dates
20 Feb 2018to 7 Jan 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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 locations and contacts

85 sites in 1 country.

85 sites in 1 country

United States85 sites

  • Investigational Site Number 8400076

    Anaheim, California, 92801-4123

  • Investigational Site Number 8400052

    Anaheim, California, 92801

  • Investigational Site Number 8400069

    Anaheim, California, 92805

  • Investigational Site Number 8400025

    Atlanta, Georgia, 30303

  • Investigational Site Number 8400051

    Atlanta, Georgia, 30310

  • Investigational Site Number 8400093

    Atlanta, Georgia, 30318

  • Investigational Site Number 8400065

    Baltimore, Maryland, 21237

  • Investigational Site Number 8400060

    Burbank, California, 91505

  • Investigational Site Number 8400049

    Cerritos, California, 90703

  • Investigational Site Number 8400079

    Chelsea, Michigan, 48118

  • Investigational Site Number 8400038

    Chicago, Illinois, 60607

  • Investigational Site Number 8400088

    Chicago, Illinois, 60607

  • Investigational Site Number 8400078

    Chula Vista, California, 91910

  • Investigational Site Number 8400043

    Columbia, South Carolina, 29204

  • Investigational Site Number 8400021

    Dallas, Texas, 75230

  • Investigational Site Number 8400031

    Des Plaines, Illinois, 60018

  • Investigational Site Number 8400054

    Englewood, Colorado, 80113

  • Investigational Site Number 8400047

    Escondido, California, 92025

  • Investigational Site Number 8400064

    Evanston, Illinois, 60201

  • Investigational Site Number 8400001

    Flint, Michigan, 48504

  • Investigational Site Number 8400012

    Flint, Michigan, 48532-3447

  • Investigational Site Number 8400040

    Fort Worth, Texas, 76132

  • Investigational Site Number 8400066

    Fountain Valley, California, 92708

  • Investigational Site Number 8400041

    Gainesville, Florida, 32653

  • Investigational Site Number 8400050

    Greenbrae, California, 94904

  • Investigational Site Number 8400030

    Gretna, Louisiana, 70053

  • Investigational Site Number 8400057

    Gurnee, Illinois, 60031

  • Investigational Site Number 8400023

    Hamden, Connecticut, 06517

  • Investigational Site Number 8400045

    Houston, Texas, 77089

  • Investigational Site Number 8400002

    Humble, Texas, 77338

  • Investigational Site Number 8400092

    Huntington Park, California, 90255

  • Investigational Site Number 8400075

    Jacksonville, Florida, 32204

  • Investigational Site Number 8400039

    Kerrville, Texas, 78028

  • Investigational Site Number 8400090

    Las Vegas, Nevada, 89117

  • Investigational Site Number 8400082

    Las Vegas, Nevada, 89148

  • Investigational Site Number 8400018

    Linden, New Jersey, 07036

  • Investigational Site Number 8400077

    Little Rock, Arkansas, 72204

  • Investigational Site Number 8400095

    Little Rock, Arkansas, 72205

  • Investigational Site Number 8400013

    Little Rock, Arkansas, 72211

  • Investigational Site Number 8400015

    Los Angeles, California, 90017

  • Investigational Site Number 8400011

    Los Angeles, California, 90057

  • Investigational Site Number 8400301

    Los Angeles, California, 90094

  • Investigational Site Number 8400302

    Los Angeles, California, 90094

  • Investigational Site Number 8400303

    Los Angeles, California, 90094

  • Investigational Site Number 8400304

    Los Angeles, California, 90094

  • Investigational Site Number 8400006

    Los Gatos, California, 95032

  • Investigational Site Number 8400096

    Lufkin, Texas, 75904

  • Investigational Site Number 8400044

    Manassas, Virginia, 20110

  • Investigational Site Number 8400036

    Miami, Florida, 33144

  • Investigational Site Number 8400017

    Miami, Florida, 33176

  • Investigational Site Number 8400016

    Miami Lakes, Florida, 33014

  • Investigational Site Number 8400072

    Montgomery, Alabama, 36106

  • Investigational Site Number 8400009

    New Orleans, Louisiana, 70124

  • Investigational Site Number 8400068

    Norfolk, Virginia, 23510

  • Investigational Site Number 8400048

    Oakland, California, 94612

  • Investigational Site Number 8400014

    Ocoee, Florida, 34761

  • Investigational Site Number 8400053

    Orange, California, 92868

  • Investigational Site Number 8400062

    Philadelphia, Pennsylvania, 19107

  • Investigational Site Number 8400084

    Pomona, California, 91766

  • Investigational Site Number 8400081

    Pomona, California, 91767

  • Investigational Site Number 8400028

    Port Charlotte, Florida, 33952

  • Investigational Site Number 8400042

    Rancho Cucamonga, California, 91730

  • Investigational Site Number 8400029

    Richland, Washington, 99352

  • Investigational Site Number 8400033

    Richmond, Virginia, 23219

  • Investigational Site Number 8400061

    Rockville, Maryland, 20852

  • Investigational Site Number 8400027

    San Antonio, Texas, 78228

  • Investigational Site Number 8400083

    San Antonio, Texas, 78230

  • Investigational Site Number 8400063

    San Carlos, California, 94070

  • Investigational Site Number 8400091

    San Diego, California, 92114

  • Investigational Site Number 8400086

    San Jose, California, 95148

  • Investigational Site Number 8400074

    Santa Ana, California, 92701

  • Investigational Site Number 8400005

    Savannah, Georgia, 31406-2675

  • Investigational Site Number 8400008

    Splendora, Texas, 77372

  • Investigational Site Number 8400055

    Spring, Texas, 77379

  • Investigational Site Number 8400097

    St. Petersburg, Florida, 00000

  • Investigational Site Number 8400035

    St. Petersburg, Florida, 33713

  • Investigational Site Number 8400070

    Sugar Land, Texas, 77478

  • Investigational Site Number 8400085

    Sugar Land, Texas, 77479

  • Investigational Site Number 8400094

    Tampa, Florida, 33634

  • Investigational Site Number 8400037

    Temecula, California, 92591

  • Investigational Site Number 8400003

    The Bronx, New York, 10455

  • Investigational Site Number 8400087

    Vallejo, California, 94592

  • Investigational Site Number 8400024

    Van Nuys, California, 91405

  • Investigational Site Number 8400007

    Ventura, California, 93003

  • Investigational Site Number 8400059

    Webster, Texas, 77598

Other trials in United States

About this study

Official title: 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).
Read more

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.
Read the 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.

Being tested
Insulin glargine/Lixisenatide, Insulin glargine (HOE901), Background therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargine/LixisenatideDrug

    Also called Soliqua 100/33, HOE901/AVE0010

    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.

  • Insulin glargine (HOE901)Drug

    Also called Lantus, 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.

  • Background therapyDrug

    Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.

Study groups in NCT03434119
Study groupRoleWhat they receive
Soliqua 100/33ExperimentalSoliqua 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.
Receives: Drug: Insulin glargine/Lixisenatide; Drug: Background therapy
LantusActive comparatorLantus (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.
Receives: Drug: Insulin glargine (HOE901); Drug: Background therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Change in HbA1c was calculated by subtracting baseline value from Week 26 value.

    Measured: Baseline, Week 26

Secondary outcomes (6)

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

    Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.

    Measured: Week 26

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

    The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.

    Measured: Baseline, Week 26

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

    Measured: Baseline, Week 26

  4. Change From Baseline in Daily Insulin Glargine Dose at Week 26

    Change in daily dose was calculated by subtracting baseline value from Week 26 value.

    Measured: Baseline, Week 26

  5. Change From Baseline in Body Weight at Week 26

    Change in body weight was calculated by subtracting baseline value from Week 26 value.

    Measured: Baseline, Week 26

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

    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.

    Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2018
  2. Study start20 Feb 2018
  3. Primary completion7 Jan 2019
  4. Study completion7 Jan 2019

Why it stopped: ("Trial terminated (recruitment delays)")

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03434119
Sponsor's protocol ID
LPS14860
Other IDs
U1111-1200-1891
Acronym
LixiLan-D
Status last verified
Mar 2022
First submitted
9 Feb 2018
Last updated
28 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine/Lixisenatide, Insulin glargine (HOE901) and Background therapy in people with Type 2 Diabetes Mellitus, run by Sanofi at 85 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03434119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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