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

NCT03434119 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: LPS14860U1111-1200-1891
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 85

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline, Week 26

Secondary Outcomes (6)

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

  Week 26

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

  Baseline, Week 26

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

  Baseline, Week 26

• Change From Baseline in Daily Insulin Glargine Dose at Week 26

  Baseline, Week 26

• Change From Baseline in Body Weight at Week 26

  Baseline, Week 26

Study Arms (2)

Soliqua 100/33

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.

Drug: Insulin glargine/Lixisenatide; Drug: Background therapy

Lantus

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.

Drug: Insulin glargine (HOE901); Drug: Background therapy

Interventions

Insulin glargine/Lixisenatide DRUG

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.

Also known as: Soliqua 100/33, HOE901/AVE0010

Soliqua 100/33

Insulin glargine (HOE901) DRUG

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.

Also known as: Lantus, HOE901

Lantus

Background therapy DRUG

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

Lantus; Soliqua 100/33

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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:
• to 50 units/day if HbA1c at Visit 1 is less than or equal to (\<=)8.5%, and
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (85)

Investigational Site Number 8400072

Montgomery, Alabama, 36106, United States

Location

Investigational Site Number 8400077

Little Rock, Arkansas, 72204, United States

Location

Investigational Site Number 8400095

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 8400013

Little Rock, Arkansas, 72211, United States

Location

Investigational Site Number 8400076

Anaheim, California, 92801-4123, United States

Location

Investigational Site Number 8400052

Anaheim, California, 92801, United States

Location

Investigational Site Number 8400069

Anaheim, California, 92805, United States

Location

Investigational Site Number 8400060

Burbank, California, 91505, United States

Location

Investigational Site Number 8400049

Cerritos, California, 90703, United States

Location

Investigational Site Number 8400078

Chula Vista, California, 91910, United States

Location

Investigational Site Number 8400047

Escondido, California, 92025, United States

Location

Investigational Site Number 8400066

Fountain Valley, California, 92708, United States

Location

Investigational Site Number 8400050

Greenbrae, California, 94904, United States

Location

Investigational Site Number 8400092

Huntington Park, California, 90255, United States

Location

Investigational Site Number 8400015

Los Angeles, California, 90017, United States

Location

Investigational Site Number 8400011

Los Angeles, California, 90057, United States

Location

Investigational Site Number 8400301

Los Angeles, California, 90094, United States

Location

Investigational Site Number 8400302

Los Angeles, California, 90094, United States

Location

Investigational Site Number 8400303

Los Angeles, California, 90094, United States

Location

Investigational Site Number 8400304

Los Angeles, California, 90094, United States

Location

Investigational Site Number 8400006

Los Gatos, California, 95032, United States

Location

Investigational Site Number 8400048

Oakland, California, 94612, United States

Location

Investigational Site Number 8400053

Orange, California, 92868, United States

Location

Investigational Site Number 8400084

Pomona, California, 91766, United States

Location

Investigational Site Number 8400081

Pomona, California, 91767, United States

Location

Investigational Site Number 8400042

Rancho Cucamonga, California, 91730, United States

Location

Investigational Site Number 8400063

San Carlos, California, 94070, United States

Location

Investigational Site Number 8400091

San Diego, California, 92114, United States

Location

Investigational Site Number 8400086

San Jose, California, 95148, United States

Location

Investigational Site Number 8400074

Santa Ana, California, 92701, United States

Location

Investigational Site Number 8400037

Temecula, California, 92591, United States

Location

Investigational Site Number 8400087

Vallejo, California, 94592, United States

Location

Investigational Site Number 8400024

Van Nuys, California, 91405, United States

Location

Investigational Site Number 8400007

Ventura, California, 93003, United States

Location

Investigational Site Number 8400054

Englewood, Colorado, 80113, United States

Location

Investigational Site Number 8400023

Hamden, Connecticut, 06517, United States

Location

Investigational Site Number 8400041

Gainesville, Florida, 32653, United States

Location

Investigational Site Number 8400075

Jacksonville, Florida, 32204, United States

Location

Investigational Site Number 8400036

Miami, Florida, 33144, United States

Location

Investigational Site Number 8400017

Miami, Florida, 33176, United States

Location

Investigational Site Number 8400016

Miami Lakes, Florida, 33014, United States

Location

Investigational Site Number 8400014

Ocoee, Florida, 34761, United States

Location

Investigational Site Number 8400028

Port Charlotte, Florida, 33952, United States

Location

Investigational Site Number 8400097

St. Petersburg, Florida, 00000, United States

Location

Investigational Site Number 8400035

St. Petersburg, Florida, 33713, United States

Location

Investigational Site Number 8400094

Tampa, Florida, 33634, United States

Location

Investigational Site Number 8400025

Atlanta, Georgia, 30303, United States

Location

Investigational Site Number 8400051

Atlanta, Georgia, 30310, United States

Location

Investigational Site Number 8400093

Atlanta, Georgia, 30318, United States

Location

Investigational Site Number 8400005

Savannah, Georgia, 31406-2675, United States

Location

Investigational Site Number 8400038

Chicago, Illinois, 60607, United States

Location

Investigational Site Number 8400088

Chicago, Illinois, 60607, United States

Location

Investigational Site Number 8400031

Des Plaines, Illinois, 60018, United States

Location

Investigational Site Number 8400064

Evanston, Illinois, 60201, United States

Location

Investigational Site Number 8400057

Gurnee, Illinois, 60031, United States

Location

Investigational Site Number 8400030

Gretna, Louisiana, 70053, United States

Location

Investigational Site Number 8400009

New Orleans, Louisiana, 70124, United States

Location

Investigational Site Number 8400065

Baltimore, Maryland, 21237, United States

Location

Investigational Site Number 8400061

Rockville, Maryland, 20852, United States

Location

Investigational Site Number 8400079

Chelsea, Michigan, 48118, United States

Location

Investigational Site Number 8400001

Flint, Michigan, 48504, United States

Location

Investigational Site Number 8400012

Flint, Michigan, 48532-3447, United States

Location

Investigational Site Number 8400090

Las Vegas, Nevada, 89117, United States

Location

Investigational Site Number 8400082

Las Vegas, Nevada, 89148, United States

Location

Investigational Site Number 8400018

Linden, New Jersey, 07036, United States

Location

Investigational Site Number 8400003

The Bronx, New York, 10455, United States

Location

Investigational Site Number 8400062

Philadelphia, Pennsylvania, 19107, United States

Location

Investigational Site Number 8400043

Columbia, South Carolina, 29204, United States

Location

Investigational Site Number 8400021

Dallas, Texas, 75230, United States

Location

Investigational Site Number 8400040

Fort Worth, Texas, 76132, United States

Location

Investigational Site Number 8400045

Houston, Texas, 77089, United States

Location

Investigational Site Number 8400002

Humble, Texas, 77338, United States

Location

Investigational Site Number 8400039

Kerrville, Texas, 78028, United States

Location

Investigational Site Number 8400096

Lufkin, Texas, 75904, United States

Location

Investigational Site Number 8400027

San Antonio, Texas, 78228, United States

Location

Investigational Site Number 8400083

San Antonio, Texas, 78230, United States

Location

Investigational Site Number 8400008

Splendora, Texas, 77372, United States

Location

Investigational Site Number 8400055

Spring, Texas, 77379, United States

Location

Investigational Site Number 8400070

Sugar Land, Texas, 77478, United States

Location

Investigational Site Number 8400085

Sugar Land, Texas, 77479, United States

Location

Investigational Site Number 8400059

Webster, Texas, 77598, United States

Location

Investigational Site Number 8400044

Manassas, Virginia, 20110, United States

Location

Investigational Site Number 8400068

Norfolk, Virginia, 23510, United States

Location

Investigational Site Number 8400033

Richmond, Virginia, 23219, United States

Location

Investigational Site Number 8400029

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Planned analysis could not be performed due to early study termination.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 15, 2018
• Study Start: February 20, 2018
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: March 28, 2022
• Results First Posted: January 13, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (85)