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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Investigational Site Number: 1560001
RECRUITING
Beijing
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2026-09-18
Participants
Target number of participants: 678
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov