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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

TerminatedPhase 3

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: Insulin glargine/Lixisenatide, Insulin glargine (HOE901), Background therapy

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (85)

Montgomery, Alabama, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Anaheim, California, United States
Anaheim, California, United States
Burbank, California, United States
Cerritos, California, United States
Chula Vista, California, United States
Escondido, California, United States
Fountain Valley, California, United States
Greenbrae, California, United States
Huntington Park, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
Oakland, California, United States
Orange, California, United States
Pomona, California, United States
Pomona, California, United States
Rancho Cucamonga, California, United States
San Carlos, California, United States
San Diego, California, United States
San Jose, California, United States
Santa Ana, California, United States
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