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Type 2 DiabetesPhase 4NCT06716424

A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus

A Phase 4 study testing iGlarLixi (insulin glargine/lixisenatide) in people with Type 2 Diabetes, run by Sanofi at 10 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
iGlarLixi (insulin glargine/lixisenatide)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
10 sitesIndia
Study dates
6 Jan 2025to 12 Jun 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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 and contacts

10 sites in 1 country.

10 sites in 1 country

India10 sites

  • Investigational Site Number : 3560009

    Bengaluru, 560054

  • Investigational Site Number : 3560007

    Delhi, 110088

  • Investigational Site Number : 3560005

    Hyderabad, 500034

  • Investigational Site Number : 3560006

    Indore, 452010

  • Investigational Site Number : 3560011

    Jaipur, 302020

  • Investigational Site Number : 3560003

    Kanpur, 208002

  • Investigational Site Number : 3560001

    Kolkata, 700020

  • Investigational Site Number : 3560008

    Pune, 411004

  • Investigational Site Number: 3560013

    Pune, 411057

  • Investigational Site Number : 3560014

    Visakhapatnam, 530040

Other trials in India

About this study

Official title: 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

This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.

Read the detailed description

The study duration will be up to 27 weeks, with a treatment duration approximately 24 weeks.

Conditions
Type 2 Diabetes
Being tested
iGlarLixi (insulin glargine/lixisenatide)
Keywords
Type 2 diabetes mellitus, Soliqua, iGlarLixi
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iGlarLixi (insulin glargine/lixisenatide)Drug

    Also called Soliqua®, Solostar®

    iGlarLixi is available as a sterile solution for injection that will be administered to study participants subcutaneously

Study groups in NCT06716424
Study groupRoleWhat they receive
iGlarLixiExperimentaliGlarLixi will be administered to study participants subcutaneously
Receives: Drug: iGlarLixi (insulin glargine/lixisenatide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)

    Measured: From Day 1 to Week 25

Secondary outcomes (8)

  1. Mean change in hemoglobin A1c (HbA1c)

    Measured: From baseline to the end of 6 months

  2. Mean change in fasting plasma glucose (FPG)

    Measured: From baseline to the end of 3 months and 6 months

  3. Mean change in 2 hours postprandial plasma glucose (PPG)

    Measured: From baseline to the end of 3 months and 6 months

  4. Mean change in fasting Self-Monitoring Plasma Glucose (SMPG)

    Measured: From baseline to the end of 3 months and 6 months

  5. Change in mean dose of iGlarLixi

    Measured: From baseline to the end of 6 months

  6. Effect of iGlarLixi on 7-point Self-Monitoring Plasma Glucose (SMPG) profile

    Measured: From baseline to the end of 3 months and 6 months

  7. Mean change in bodyweight

    Measured: From baseline to the end of 6 months

  8. Percentage of participants with at least one hypoglycaemic episode

    Hypoglycaemic episodes: American Diabetes Association (ADA) level 1, 2 or 3

    Measured: From Day 1 to Week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start6 Jan 2025
  3. Primary completion12 Jun 2026
  4. Study completion12 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06716424
Sponsor's protocol ID
LPS18016
Other IDs
U1111-1303-3494
Status last verified
Jul 2026
First submitted
29 Nov 2024
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing iGlarLixi (insulin glargine/lixisenatide) in people with Type 2 Diabetes, run by Sanofi at 10 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs) (time frame: From Day 1 to Week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06716424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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