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Type 2 Diabetes (T2D)Phase 4China Soli-CGMNCT06671587

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

A Phase 4 study testing iGlarLixi (insulin glargine/lixisenatide) and Gla-100 (insulin glargine) in people with Type 2 Diabetes (T2D), run by Sanofi at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes (T2D)
What is being tested?
iGlarLixi (insulin glargine/lixisenatide) and Gla-100 (insulin glargine)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
678 participants
Where
1 siteChina
Study dates
10 Dec 2024to 18 Sep 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 who are diagnosed as T2D of at least 1 year before screening visit
  • Participants who are treated at least 3 months prior to screening visit with a stable dose of metformin alone or in combination with a second OAD
  • Inadequate control
  • Body mass index (BMI) within the range 20-40 kg/m2 (inclusive)
  • Is willing and able to wear the CGM device continuously
  • Is willing to discontinue daily (oral) SU, glinide, alpha-GI, and DPP-4i
  • Not using another CGM device during the study

Who cannot join

  • Participants with severe renal dysfunction
  • Participants with short life expectancy
  • Participants with conditions/concomitant diseases making them non evaluable for the efficacy endpoints
  • Participants with conditions/concomitant diseases precluding their safe participation in this study
  • An episode of severe hypoglycemia requiring the assistance of a third party within 3 months before screening visit
  • History of clinically significant pancreatitis or severe gastrointestinal disorders
Show all 16Show fewer
  • Participants who have any history of severe multiple allergies or an allergy resulting in anaphylaxis, or contraindication/hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
  • Previous treatment with insulin
  • Use of any glucose-lowering agents other than metformin alone or in combination with a second OAD (can be a SU, a glinide, an alpha-GI, a DPP-4i, or a SGLT-2i)
  • Use of systemic glucocorticoids
  • Use of weight loss drugs
  • History of discontinuation of a previous treatment with GLP-1 RA for safety/tolerability reasons or lack of efficacy
  • Laboratory findings at the screening visit
  • Participants have any current or previous skin conditions
  • Participants unwilling or unable to do blood glucose monitoring using the Sponsor-provided blood glucometer at home
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

contact-us@sanofi.com

China1 site, 1 recruiting

  • Investigational Site Number: 1560001

    Beijing, 100730

    Recruiting

Other trials in China

About this study

Official title: A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics

This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group). The randomization (1:1) will be stratified by values of HbA1c at screening (<8.0%, ≥8.0%), and background treatment (metformin only, metformin+SGLT-2i).

Study details include:

  • The study duration per participant will be approximately up to 24 weeks.
  • The treatment duration will be up to 20 weeks.
  • The number of visits will be 14 visits including 9 times of on-site visits and 5 times of phone call visits in total during screening and treatment periods. On-site every 1 week will be from screening till randomization (Week 0), then on site or phone call visit every 2 weeks till Week 12, then every 3 weeks till Week 18, and the End of Treatment visit will be conducted at Week 20. There will be a safety follow-up by a phone call visit (End of Study) in 3 days (-1/+3 days) after the last dose of the treatment.
  • Health measurement/Observation: change in TIR as the primary endpoint
  • Intervention name: iGlarLixi and Gla-100
  • Participant gender: male and female
  • Participant age range: adults at least 18 years of age
  • Condition/disease: type 2 diabetes
  • Study hypothesis: compared to Gla-100, iGlarLixi will demonstrate a superiority therapeutic effect on glycemic control assessed by change in TIR measured with CGM from baseline to Week 20 in the study participants.
Being tested
iGlarLixi (insulin glargine/lixisenatide), Gla-100 (insulin glargine)
Keywords
Glucagon-like peptide-1 receptor agonist (GLP-1 RA), FRC (fixed ration combination)
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®

    iGlarLixi will be supplied as a sterile aqueous solution in a pen-injector.

    There will be 2 pen-injectors with different insulin glargine/lixisenatide fixed ratios which allow insulin glargine titration from 5 U/day to 40 U/day while limiting lixisenatide dose to a maximum of 20 μg/day:

    • iGlarLixi must not be mixed with other insulins nor diluted.

  • Gla-100 (insulin glargine)Drug

    Also called LANTUS®

    Gla-100 will be supplied as a 3 mL sterile aqueous solution for SC injection in a pre-filled disposable Gla-100 SoloStar® pen containing 300 U insulin glargine (100 U/mL). Doses could be set in the range of 5 to 80 U in increments of 1 unit.

Study groups in NCT06671587
Study groupRoleWhat they receive
iGlarLixi (insulin glargine/lixisenatide)ExperimentalParticipants will receive iGlarLixi once daily for 20 weeks. iGlarLixi is to be initiated with the starting daily dose of 5-10 dose steps on Visit 4 (Day 1) and will be titrated according to fasting SMBG to achieve glycemic target of ≥80 and ≤110 mg/dL.
Receives: Drug: iGlarLixi (insulin glargine/lixisenatide)
Gla-100 (insulin glargine)Active comparatorParticipants will receive Gla-100 once daily for 20 weeks. Gla-100 is to be initiated with the starting daily dose of 5-10 U on Visit 4 (Day 1) and will be titrated according to fasting SMBG to achieve and maintain same glycemic target of ≥80 and ≤110 mg/dL.
Receives: Drug: Gla-100 (insulin glargine)

What is being measured

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

  1. Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)]

    Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)] from baseline to Week 20 of iGlarLixi vs Gla-100

    Measured: from baseline to Week 20

Secondary outcomes (30)

  1. 2a Proportion (%) of participants achieving TIR target as >70%

    Measured: Week 20

  2. 2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL)

    Measured: from baseline to Week 20

  3. 2c Change (mg/dL) in mean daily glucose

    Measured: from baseline to Week 20

  4. 2d Proportion (%) of participants achieving composite target of TIR as >70% [3.9-10.0 mmol/L (70-180 mg/dL)] with TAR as <25% [>10.0 mmol/L (>180 mg/dL)] with TBR as <4% [<3.9 mmol/L (<70 m)/dL)]

    Measured: Week 20

  5. Change (%) in coefficient of variation (CV)

    Measured: from baseline to Week 20

  6. Change (%) in the percentage of time in tight range (TITR) [3.9-7.8 mmol/L (70-140 mg/dL)]

    Measured: from baseline to Week 20

  7. Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50%

    Measured: Week 20

  8. Proportion (%) of participants achieving ≥5% TIR improvement

    Measured: from baseline to Week 20

  9. Proportion (%) of participants achieving ≥10% TIR improvement

    Measured: from baseline to Week 20

  10. Change (%) in TAR >13.9 mmol/L (>250 mg/dL)

    Measured: from baseline to Week 20

  11. Change (%) in time below range (TBR)

    • <3.9 mmol/L (<70 mg/dL), including <3.0 mmol/L (<54 mg/dL)
    • <3.0 mmol/L (<54 mg/dL)
    • <3.9 mmol/L (<70 mg/dL), including <3.0 mmol/L (<54 mg/dL) in nocturnal (00:00 h-05:59 h) time
    • <3.0 mmol/L (<54 mg/dL) in nocturnal (00:00 h-05:59 h) time

    Measured: from baseline to Week 20

  12. Change in mean glucose standard deviation (SD)

    Measured: from baseline to Week 20

  13. Change (%) in glucose management indicator (GMI)

    Measured: from baseline to Week 20

  14. Proportion (%) of participants achieving CV <36%

    Measured: Week 20

  15. Proportion (%) of participants achieving CV <32%

    Measured: Week 20

  16. Change (%) in HbA1c

    Measured: from baseline to Week 12 and Week 20

  17. Proportion (%) of participants achieving HbA1c <7%

    Measured: Week 12 and Week 20

  18. Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia

    documented hypoglycemia (defined as ADA Level 1, 2 or 3)

    Measured: Week 20

  19. Proportion (%) of participants achieving HbA1c <7% without body weight gain

    body weight gain (≥5% compared to baseline)

    Measured: Week 20

  20. Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia and without body weight gain

    documented hypoglycemia (defined as ADA Level 1, 2 or 3)

    Measured: Week 20

  21. Change (mmol/L) in fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG)

    Measured: from baseline to Week 12 and Week 20

  22. Change (nmol/L) in fasting C-peptide and post-prandial C-peptide

    Measured: from baseline to Week 12 and Week 20

  23. Change (U and U/Kg) in insulin dose

    Measured: from baseline to Week 20

  24. Change (kg) in body weight

    Measured: from baseline to Week 20

  25. Change (%) in TIR [3.9-10.0 mmol/L (70-180 mg/dL)], TAR [>10.0 mmol/L (>180 mg/dL)] and TBR [3.0 mmol/L (<54 mg/dL)] for specific time blocks (6 am-12 pm, 12 pm-6 pm, 6 pm-12 am, and 12 am-6 am)

    Measured: from baseline to Week 20

  26. Change in diabetes medication treatment satisfaction scores (total score and by subscales), using the treatment-related impact measure diabetes (TRIM-D) questionnaire

    Measured: from baseline to Week 20

  27. AE, serious adverse event (SAE), and adverse event of special interest (AESI)

    Measured: from screening to week 21

  28. Overall hypoglycemia events and rates

    Measured: from screening to week 21

  29. Nocturnal (00:00 h-05:59 h) hypoglycemia events and rates

    Measured: from baseline to Week 20

  30. Confirmed hypoglycemia (ADA Level 1, 2 and 3)

    • ADA Level 1: Measurable glucose concentration <70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L)
    • ADA Level 2: Measurable glucose concentration <54 mg/dL (3.0 mmol/L) that needs immediate action
    • ADA Level 3: Severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery

    Measured: from baseline to Week 20

Timeline

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

  1. First posted4 Nov 2024
  2. Study start10 Dec 2024
  3. Primary completion18 Sep 2026 (estimated)
  4. Study completion18 Sep 2026 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study comparing iGlarLixi to Gla-100.
Masking
None (open label)
Enrolment
678 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06671587
Sponsor's protocol ID
LPS18034
Other IDs
U1111-1306-6660
Acronym
China Soli-CGM
Status last verified
Mar 2026
First submitted
31 Oct 2024
Last updated
17 Mar 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) and Gla-100 (insulin glargine) in people with Type 2 Diabetes (T2D), run by Sanofi at 1 site in China.

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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)] (time frame: from baseline to Week 20). 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 NCT06671587.

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 17 Mar 2026.

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