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Trial · Interventional

RecruitingPhase 4Registry data

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

Short name China Soli-CGM

NCTNCT06671587 (opens ClinicalTrials.gov in a new tab)Other idLPS18034Other idU1111-1306-6660
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
678 participants (estimated)
Sponsor
Sanofi · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
10 Dec 2024
Primary completion
18 Sept 2026 (estimated)
Completion
18 Sept 2026 (estimated)
First posted
4 Nov 2024
Last update posted
17 Mar 2026
Conditions
Type 2 Diabetes (T2D)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 4

    China Soli-CGM

    NCT06671587

    10 Dec 2024 to est. 18 Sept 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • iGlarLixi (insulin glargine/lixisenatide)Drug
  • Gla-100 (insulin glargine)Drug

Arms2

  • Experimental

    iGlarLixi (insulin glargine/lixisenatide)

    Participants 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.

  • Active comparator

    Gla-100 (insulin glargine)

    Participants 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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(20)

  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

    Registry description

    * \<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

    Registry description

    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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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