LixiLan-DSoliqua™100/33 vs Lantus® for Type 2 Diabetes Mellitus in Diverse Patients Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
This study aims to compare the effectiveness of Soliqua™100/33 and Lantus® in managing Type 2 Diabetes Mellitus in diverse patients who are not adequately controlled with basal insulin and oral antidiabetic agents, by observing the change in Glycated Hemoglobin (HbA1c) levels from the beginning to the 26th week.
Insulin glargine/Lixisenatide
+ Background therapy
+ Insulin glargine (HOE901)
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: February 20, 2018
Actual date on which the first participant was enrolled.This study focuses on comparing the effectiveness and safety of two diabetes treatments, Soliqua™100/33 and Lantus®, in ethnically and racially diverse patients with Type 2 Diabetes Mellitus. These patients have not been able to control their diabetes adequately with basal insulin and oral antidiabetic medications. The research aims to find a better treatment option for this group of patients, potentially improving their diabetes management and overall health. The study lasts for about 29 weeks, including a 2-week screening period, a 26-week treatment period, and a 3-day follow-up period. During the treatment period, participants receive either Soliqua™100/33 or Lantus®. The main outcome measured is the change in glycated hemoglobin (HbA1c) levels from the start to the end of the 26-week treatment period. This change is calculated by subtracting the baseline HbA1c value from the value at week 26, indicating how well the treatments control blood sugar levels.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.241 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 85 locations
Investigational Site Number 8400072
Montgomery, United StatesOpen Investigational Site Number 8400072 in Google MapsInvestigational Site Number 8400077
Little Rock, United StatesInvestigational Site Number 8400095
Little Rock, United StatesInvestigational Site Number 8400013
Little Rock, United States