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NCT Number: NCT06671587

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

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.

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Key information

Conditions

Type 2 Diabetes (T2D) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number: 1560001

Beijing, 100730, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

iGlarLixi (insulin glargine/lixisenatide)

Drug

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.

Other names: SOLIQUA®

Gla-100 (insulin glargine)

Drug

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.

Other names: LANTUS®

Primary outcomes

  1. 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

    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

Secondary outcomes

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

    Time frame: Week 20

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

    Time frame: from baseline to Week 20

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

    Time frame: 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)]

    Time frame: Week 20

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

    Time frame: 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)]

    Time frame: from baseline to Week 20

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

    Time frame: Week 20

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

    Time frame: from baseline to Week 20

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

    Time frame: from baseline to Week 20

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

    Time frame: from baseline to Week 20

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

    Time frame: from baseline to Week 20

    • <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

  12. Change in mean glucose standard deviation (SD)

    Time frame: from baseline to Week 20

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

    Time frame: from baseline to Week 20

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

    Time frame: Week 20

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

    Time frame: Week 20

  16. Change (%) in HbA1c

    Time frame: from baseline to Week 12 and Week 20

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

    Time frame: Week 12 and Week 20

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

    Time frame: Week 20

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

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

    Time frame: Week 20

    body weight gain (≥5% compared to baseline)

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

    Time frame: Week 20

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

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

    Time frame: from baseline to Week 12 and Week 20

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

    Time frame: from baseline to Week 12 and Week 20

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

    Time frame: from baseline to Week 20

  24. Change (kg) in body weight

    Time frame: 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)

    Time frame: 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

    Time frame: from baseline to Week 20

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

    Time frame: from screening to week 21

  28. Overall hypoglycemia events and rates

    Time frame: from screening to week 21

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

    Time frame: from baseline to Week 20

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

    Time frame: from baseline to Week 20

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: China Soli-CGM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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