Multicentre Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RA
New Trial Tests iGlarLixi for Type 2 Diabetes in India
Plain English Summary
A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus is a Phase 4 clinical trial sponsored by Sanofi studying Type 2 Diabetes. This trial tests a combination medication called iGlarLixi (insulin glargine and lixisenatide) for adults with Type 2 diabetes. It is for adults with Type 2 diabetes who are not well-controlled with current oral medications or basal insulin/GLP-1 receptor agonists. Participants will receive iGlarLixi injections and be monitored for safety and effectiveness over about 6 months. Alternative treatments include other combinations of diabetes medications, different insulin types, or lifestyle changes. The trial aims to enroll 105 participants.
Official Summary
This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with Type 2 diabetes diagnosed for at least one year. Individuals whose diabetes is not well-controlled (HbA1c between 7.5% and 10.5%) and are on metformin or other oral drugs, or basal insulin/GLP-1 RA. Participants must have a BMI of 25 kg/m2 or higher. Women of childbearing potential must agree to use contraception. This trial is studying Type 2 Diabetes, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how often participants experience any new side effects or serious adverse events while taking the study medication. The specific primary outcome measures are: Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) (From Day 1 to Week 25). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial matters because it investigates a new combination therapy for Type 2 diabetes patients who haven't achieved good control with existing treatments, potentially offering a more effective opti This research targets Type 2 Diabetes, where improved treatment options are needed.
Investor Insight
This Phase IV trial by Sanofi evaluates a fixed-ratio combination drug, suggesting a focus on optimizing existing treatments for a large market of Type 2 diabetes patients with suboptimal control. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor if iGlarLixi is a suitable option for your diabetes management and what potential benefits and risks it may have. Participation involves regular study visits for about 6 months, including blood tests and injections of the study medication. You will need to monitor your blood sugar levels and report any side effects or changes in your health to the study team. The trial is being conducted at 10 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 105 participants
Interventions
- DRUG: iGlarLixi (insulin glargine/lixisenatide) — iGlarLixi is available as a sterile solution for injection that will be administered to study participants subcutaneously
Primary Outcomes
- Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) (From Day 1 to Week 25)
Secondary Outcomes
- Mean change in hemoglobin A1c (HbA1c) (From baseline to the end of 6 months)
- Mean change in fasting plasma glucose (FPG) (From baseline to the end of 3 months and 6 months)
- Mean change in 2 hours postprandial plasma glucose (PPG) (From baseline to the end of 3 months and 6 months)
- Mean change in fasting Self-Monitoring Plasma Glucose (SMPG) (From baseline to the end of 3 months and 6 months)
- Change in mean dose of iGlarLixi (From baseline to the end of 6 months)
Full Eligibility Criteria
Inclusion Criteria: * Participants must be ≥18 years of age, at the time of signing the informed consent * Participants with Type 2 Diabetes diagnosed for at least 1 year at the time of screening on treatment with Metformin +/- OADs or basal insulin/GLP-1RA for a minimum period of 6 months prior to screening * HbA1c between ≥ 7.5% and ≤10.5% inclusive, during screening * Participant with BMI \>= 25 kg/m2 (as per Endocrine Society of India, Ref 12) * Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (i.e., until Week 27) * Signed informed consent Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Type 1 Diabetes mellitus or any diabetes other than T2DM * Prior use of any combination of Basal Insulin + GLP-1 RA Fixed Ratio or Free Combination, Premix Insulin, Basal bolus therapy * Basal insulin dose \>50 U at screening * Any clinically-significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the Investigator would preclude safe completion of the study or constrains efficacy assessment * Known presence of factors that interfere with the HbA1c measurement (e.g., specific hemoglobin variants, hemolytic anemia) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (e.g., blood transfusion or severe blood loss in the last 3 months prior to baseline, any condition that shortens erythrocyte survival) * History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit * Proliferative retinopathy or maculopathy requiring treatment according to the Investigator * Use of weight loss drugs (including over-the-counter and herbal medications) within 12 Weeks prior to the screening visit * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit * Likelihood to require treatment prohibited by the protocol during the study. * Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, prior to screening visit or concomitant enrollment in any other clinical study involving an investigational study treatment * Any specific situation during study implementation/course that may raise ethics considerations * History of hypoglycemia unawareness * Patients with known hypersensitivity to lixisenatide, insulin glargine or to any of the inactive ingredients in the formulation * History of drug or alcohol abuse within 6 months prior to screening visit The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial Locations
- Investigational Site Number : 3560009, Bengaluru, India
- Investigational Site Number : 3560007, Delhi, India
- Investigational Site Number : 3560005, Hyderabad, India
- Investigational Site Number : 3560006, Indore, India
- Investigational Site Number : 3560011, Jaipur, India
- Investigational Site Number : 3560003, Kanpur, India
- Investigational Site Number : 3560001, Kolkata, India
- Investigational Site Number : 3560008, Pune, India
- Investigational Site Number: 3560013, Pune, India
- Investigational Site Number : 3560014, Visakhapatnam, India
Frequently Asked Questions
What is clinical trial NCT06716424?
NCT06716424 is a Phase 4 INTERVENTIONAL study titled "A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus." It is currently active, not recruiting and is sponsored by Sanofi. The trial targets enrollment of 105 participants.
What conditions does NCT06716424 study?
This trial investigates treatments for Type 2 Diabetes. The primary condition under study is Type 2 Diabetes.
What treatments are being tested in NCT06716424?
The interventions being studied include: iGlarLixi (insulin glargine/lixisenatide) (DRUG). iGlarLixi is available as a sterile solution for injection that will be administered to study participants subcutaneously
What does Phase 4 mean for NCT06716424?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT06716424?
This trial is currently "Active, Not Recruiting." It started on 2025-01-06. The estimated completion date is 2026-06-26.
Who is sponsoring NCT06716424?
NCT06716424 is sponsored by Sanofi. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06716424?
The trial aims to enroll 105 participants. The trial status is active, not recruiting.
How is NCT06716424 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06716424?
The primary outcome measures are: Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) (From Day 1 to Week 25). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06716424 being conducted?
This trial is being conducted at 10 sites, including Bengaluru; Delhi; Hyderabad; Indore and 6 more sites (India).
Where can I find official information about NCT06716424?
The official record for NCT06716424 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06716424. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06716424 testing in simple terms?
This trial tests a combination medication called iGlarLixi (insulin glargine and lixisenatide) for adults with Type 2 diabetes. It is for adults with Type 2 diabetes who are not well-controlled with current oral medications or basal insulin/GLP-1 receptor agonists.
Why is this trial significant?
This trial matters because it investigates a new combination therapy for Type 2 diabetes patients who haven't achieved good control with existing treatments, potentially offering a more effective opti
What are the potential risks of participating in NCT06716424?
The most common risks include low blood sugar (hypoglycemia), nausea, vomiting, and diarrhea. Some participants may experience injection site reactions like redness or swelling. Serious side effects, though rare, can include allergic reactions or pancreatitis. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06716424?
Ask your doctor if iGlarLixi is a suitable option for your diabetes management and what potential benefits and risks it may have. Participation involves regular study visits for about 6 months, including blood tests and injections of the study medication. You will need to monitor your blood sugar levels and report any side effects or changes in your health to the study team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06716424 signal from an investment perspective?
This Phase IV trial by Sanofi evaluates a fixed-ratio combination drug, suggesting a focus on optimizing existing treatments for a large market of Type 2 diabetes patients with suboptimal control. This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive iGlarLixi injections and be monitored for safety and effectiveness over about 6 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.