Status
Recruiting
Phase
Phase 4
Enrollment
678
Locations
1
Results
Not posted
Publications
0
Study 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 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
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.
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.
Timeline
First posted
Nov 4, 2024
Study start
Dec 10, 2024
Primary completion
Sep 18, 2026
Study completion
Sep 18, 2026
Results posted
Not reported
Registry updated
Mar 17, 2026
Outcomes
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
2a Proportion (%) of participants achieving TIR target as >70%
Time frame · Week 20
2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL)
Time frame · from baseline to Week 20
2c Change (mg/dL) in mean daily glucose
Time frame · from baseline to Week 20
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
Change (%) in coefficient of variation (CV)
Time frame · from baseline to Week 20
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
Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50%
Time frame · Week 20
Proportion (%) of participants achieving ≥5% TIR improvement
Time frame · from baseline to Week 20
Proportion (%) of participants achieving ≥10% TIR improvement
Time frame · from baseline to Week 20
Change (%) in TAR >13.9 mmol/L (>250 mg/dL)
Time frame · from baseline to Week 20
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Investigational Site Number: 1560001
Beijing, China
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Sanofi · Type 2 Diabetes
Phase 4
Completed
105
2026-07
Shanghai Zhongshan Hospital · Type 2 Diabetes
Phase 4
Recruiting
1,316
2026-07
Brigham and Women's Hospital · Cardiovascular Events · Type2 Diabetes
Not applicable
Active, not recruiting
781,430
2026-05
Yanbing Li · Type 2 Diabetes
Phase 4
Not yet recruiting
324
2026-02
University Hospital, Toulouse · Parkinson Disease
Phase 2
Completed
156
2025-11
Sanofi · Type 2 Diabetes Mellitus
Phase 3
Completed
582
2025-09
Ohio State University · Cardiovascular Kidney Metabolic Syndrome
Not applicable
Active, not recruiting
23,280,000
2025-09
Medical University of Warsaw · Steroid-Induced Diabetes · Steroid-Induced Hyperglycemia
Phase 4
Enrolling by invitation
100
2025-09
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.