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

Phase 3TerminatedNCT03434119

Sanofi241 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

241

Conditions

Type 2 Diabetes Mellitus

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Investigational Site Number 8400072

Montgomery, Alabama, United States

Investigational Site Number 8400077

Little Rock, Arkansas, United States

Investigational Site Number 8400095

Little Rock, Arkansas, United States

Investigational Site Number 8400013

Little Rock, Arkansas, United States

Investigational Site Number 8400076

Anaheim, California, United States

Outcomes

Primary Outcomes

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

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

Time frame: Baseline, Week 26

Secondary Outcomes

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.

Time frame: Week 26

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.

Time frame: Baseline, Week 26

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

Time frame: Baseline, Week 26

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.

Time frame: Baseline, Week 26

Change From Baseline in Body Weight at Week 26

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

Time frame: Baseline, Week 26

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.

Time frame: Baseline to Week 26