Clinical trial NCT03434119: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-02-15
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Percentage of Participants Achieving HbA1c Target of <7% at Week 26
timeFrame: Week 26
measure: Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Daily Insulin Glargine Dose at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Body Weight at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Investigational Site Number 8400072
state: Alabama
city: Little Rock
country: United States
facility: Investigational Site Number 8400077
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 8400095
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 8400013
state: Arkansas
city: Anaheim
country: United States
facility: Investigational Site Number 8400076
state: California
city: Anaheim
country: United States
facility: Investigational Site Number 8400052
state: California
city: Anaheim
country: United States
facility: Investigational Site Number 8400069
state: California
city: Burbank
country: United States
facility: Investigational Site Number 8400060
state: California
city: Cerritos
country: United States
facility: Investigational Site Number 8400049
state: California
city: Chula Vista
country: United States
facility: Investigational Site Number 8400078
state: California
city: Escondido
country: United States
facility: Investigational Site Number 8400047
state: California
city: Fountain Valley
country: United States
facility: Investigational Site Number 8400066
state: California
city: Greenbrae
country: United States
facility: Investigational Site Number 8400050
state: California
city: Huntington Park
country: United States
facility: Investigational Site Number 8400092
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8400015
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8400011
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8400301
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8400302
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8400303
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8400304
state: California
city: Los Gatos
country: United States
facility: Investigational Site Number 8400006
state: California
city: Oakland
country: United States
facility: Investigational Site Number 8400048
state: California
city: Orange
country: United States
facility: Investigational Site Number 8400053
state: California
city: Pomona
country: United States
facility: Investigational Site Number 8400084
state: California
city: Pomona
country: United States
facility: Investigational Site Number 8400081
state: California
city: Rancho Cucamonga
country: United States
facility: Investigational Site Number 8400042
state: California
city: San Carlos
country: United States
facility: Investigational Site Number 8400063
state: California
city: San Diego
country: United States
facility: Investigational Site Number 8400091
state: California
city: San Jose
country: United States
facility: Investigational Site Number 8400086
state: California
city: Santa Ana
country: United States
facility: Investigational Site Number 8400074
state: California
city: Temecula
country: United States
facility: Investigational Site Number 8400037
state: California
city: Vallejo
country: United States
facility: Investigational Site Number 8400087
state: California
city: Van Nuys
country: United States
facility: Investigational Site Number 8400024
state: California
city: Ventura
country: United States
facility: Investigational Site Number 8400007
state: California
city: Englewood
country: United States
facility: Investigational Site Number 8400054
state: Colorado
city: Hamden
country: United States
facility: Investigational Site Number 8400023
state: Connecticut
city: Gainesville
country: United States
facility: Investigational Site Number 8400041
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 8400075
state: Florida
city: Miami Lakes
country: United States
facility: Investigational Site Number 8400016
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 8400036
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 8400017
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 8400014
state: Florida
city: Port Charlotte
country: United States
facility: Investigational Site Number 8400028
state: Florida
city: Saint Petersburg
country: United States
facility: Investigational Site Number 8400097
state: Florida
city: Saint Petersburg
country: United States
facility: Investigational Site Number 8400035
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 8400094
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 8400025
state: Georgia
city: Atlanta
country: United States
facility: Investigational Site Number 8400051
state: Georgia
city: Atlanta
country: United States
facility: Investigational Site Number 8400093
state: Georgia
city: Savannah
country: United States
facility: Investigational Site Number 8400005
state: Georgia
city: Chicago
country: United States
facility: Investigational Site Number 8400038
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 8400088
state: Illinois
city: Des Plaines
country: United States
facility: Investigational Site Number 8400031
state: Illinois
city: Evanston
country: United States
facility: Investigational Site Number 8400064
state: Illinois
city: Gurnee
country: United States
facility: Investigational Site Number 8400057
state: Illinois
city: Gretna
country: United States
facility: Investigational Site Number 8400030
state: Louisiana
city: New Orleans
country: United States
facility: Investigational Site Number 8400009
state: Louisiana
city: Baltimore
country: United States
facility: Investigational Site Number 8400065
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 8400061
state: Maryland
city: Chelsea
country: United States
facility: Investigational Site Number 8400079
state: Michigan
city: Flint
country: United States
facility: Investigational Site Number 8400001
state: Michigan
city: Flint
country: United States
facility: Investigational Site Number 8400012
state: Michigan
city: Las Vegas
country: United States
facility: Investigational Site Number 8400090
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 8400082
state: Nevada
city: Linden
country: United States
facility: Investigational Site Number 8400018
state: New Jersey
city: Bronx
country: United States
facility: Investigational Site Number 8400003
state: New York
city: Philadelphia
country: United States
facility: Investigational Site Number 8400062
state: Pennsylvania
city: Columbia
country: United States
facility: Investigational Site Number 8400043
state: South Carolina
city: Dallas
country: United States
facility: Investigational Site Number 8400021
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 8400040
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 8400045
state: Texas
city: Humble
country: United States
facility: Investigational Site Number 8400002
state: Texas
city: Kerrville
country: United States
facility: Investigational Site Number 8400039
state: Texas
city: Lufkin
country: United States
facility: Investigational Site Number 8400096
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8400027
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8400083
state: Texas
city: Splendora
country: United States
facility: Investigational Site Number 8400008
state: Texas
city: Spring
country: United States
facility: Investigational Site Number 8400055
state: Texas
city: Sugar Land
country: United States
facility: Investigational Site Number 8400070
state: Texas
city: Sugar Land
country: United States
facility: Investigational Site Number 8400085
state: Texas
city: Webster
country: United States
facility: Investigational Site Number 8400059
state: Texas
city: Manassas
country: United States
facility: Investigational Site Number 8400044
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 8400068
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 8400033
state: Virginia
city: Richland
country: United States
facility: Investigational Site Number 8400029
state: Washington
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: