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

Type 2 Diabetes Mellitus Clinical Trial

— LixiLan-D  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03434119
• Other study ID #: LPS14860
• Secondary ID: U1111-1200-1891
• Status: Terminated
• Phase: Phase 3
• Start date: February 20, 2018
• Est. completion date: January 7, 2019

Study information

• Verified date: March 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 241
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Investigational Site Number 8400052	Anaheim	California
United States	Investigational Site Number 8400069	Anaheim	California
United States	Investigational Site Number 8400076	Anaheim	California
United States	Investigational Site Number 8400025	Atlanta	Georgia
United States	Investigational Site Number 8400051	Atlanta	Georgia
United States	Investigational Site Number 8400093	Atlanta	Georgia
United States	Investigational Site Number 8400065	Baltimore	Maryland
United States	Investigational Site Number 8400003	Bronx	New York
United States	Investigational Site Number 8400060	Burbank	California
United States	Investigational Site Number 8400049	Cerritos	California
United States	Investigational Site Number 8400079	Chelsea	Michigan
United States	Investigational Site Number 8400038	Chicago	Illinois
United States	Investigational Site Number 8400088	Chicago	Illinois
United States	Investigational Site Number 8400078	Chula Vista	California
United States	Investigational Site Number 8400043	Columbia	South Carolina
United States	Investigational Site Number 8400021	Dallas	Texas
United States	Investigational Site Number 8400031	Des Plaines	Illinois
United States	Investigational Site Number 8400054	Englewood	Colorado
United States	Investigational Site Number 8400047	Escondido	California
United States	Investigational Site Number 8400064	Evanston	Illinois
United States	Investigational Site Number 8400001	Flint	Michigan
United States	Investigational Site Number 8400012	Flint	Michigan
United States	Investigational Site Number 8400040	Fort Worth	Texas
United States	Investigational Site Number 8400066	Fountain Valley	California
United States	Investigational Site Number 8400041	Gainesville	Florida
United States	Investigational Site Number 8400050	Greenbrae	California
United States	Investigational Site Number 8400030	Gretna	Louisiana
United States	Investigational Site Number 8400057	Gurnee	Illinois
United States	Investigational Site Number 8400023	Hamden	Connecticut
United States	Investigational Site Number 8400045	Houston	Texas
United States	Investigational Site Number 8400002	Humble	Texas
United States	Investigational Site Number 8400092	Huntington Park	California
United States	Investigational Site Number 8400075	Jacksonville	Florida
United States	Investigational Site Number 8400039	Kerrville	Texas
United States	Investigational Site Number 8400082	Las Vegas	Nevada
United States	Investigational Site Number 8400090	Las Vegas	Nevada
United States	Investigational Site Number 8400018	Linden	New Jersey
United States	Investigational Site Number 8400013	Little Rock	Arkansas
United States	Investigational Site Number 8400077	Little Rock	Arkansas
United States	Investigational Site Number 8400095	Little Rock	Arkansas
United States	Investigational Site Number 8400011	Los Angeles	California
United States	Investigational Site Number 8400015	Los Angeles	California
United States	Investigational Site Number 8400301	Los Angeles	California
United States	Investigational Site Number 8400302	Los Angeles	California
United States	Investigational Site Number 8400303	Los Angeles	California
United States	Investigational Site Number 8400304	Los Angeles	California
United States	Investigational Site Number 8400006	Los Gatos	California
United States	Investigational Site Number 8400096	Lufkin	Texas
United States	Investigational Site Number 8400044	Manassas	Virginia
United States	Investigational Site Number 8400017	Miami	Florida
United States	Investigational Site Number 8400036	Miami	Florida
United States	Investigational Site Number 8400016	Miami Lakes	Florida
United States	Investigational Site Number 8400072	Montgomery	Alabama
United States	Investigational Site Number 8400009	New Orleans	Louisiana
United States	Investigational Site Number 8400068	Norfolk	Virginia
United States	Investigational Site Number 8400048	Oakland	California
United States	Investigational Site Number 8400014	Ocoee	Florida
United States	Investigational Site Number 8400053	Orange	California
United States	Investigational Site Number 8400062	Philadelphia	Pennsylvania
United States	Investigational Site Number 8400081	Pomona	California
United States	Investigational Site Number 8400084	Pomona	California
United States	Investigational Site Number 8400028	Port Charlotte	Florida
United States	Investigational Site Number 8400042	Rancho Cucamonga	California
United States	Investigational Site Number 8400029	Richland	Washington
United States	Investigational Site Number 8400033	Richmond	Virginia
United States	Investigational Site Number 8400061	Rockville	Maryland
United States	Investigational Site Number 8400035	Saint Petersburg	Florida
United States	Investigational Site Number 8400097	Saint Petersburg	Florida
United States	Investigational Site Number 8400027	San Antonio	Texas
United States	Investigational Site Number 8400083	San Antonio	Texas
United States	Investigational Site Number 8400063	San Carlos	California
United States	Investigational Site Number 8400091	San Diego	California
United States	Investigational Site Number 8400086	San Jose	California
United States	Investigational Site Number 8400074	Santa Ana	California
United States	Investigational Site Number 8400005	Savannah	Georgia
United States	Investigational Site Number 8400008	Splendora	Texas
United States	Investigational Site Number 8400055	Spring	Texas
United States	Investigational Site Number 8400070	Sugar Land	Texas
United States	Investigational Site Number 8400085	Sugar Land	Texas
United States	Investigational Site Number 8400094	Tampa	Florida
United States	Investigational Site Number 8400037	Temecula	California
United States	Investigational Site Number 8400087	Vallejo	California
United States	Investigational Site Number 8400024	Van Nuys	California
United States	Investigational Site Number 8400007	Ventura	California
United States	Investigational Site Number 8400059	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 26
Secondary	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.	Baseline, Week 26
Secondary	Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26		Baseline, Week 26
Secondary	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.	Baseline, Week 26
Secondary	Change From Baseline in Body Weight at Week 26	Change in body weight was calculated by subtracting baseline value from Week 26 value.	Baseline, Week 26
Secondary	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.	Baseline to Week 26