iGlarLixi CGM Study in Chinese T2D Individuals After OADs

NCT ID: NCT06671587

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 678 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2026-09-18

Brief 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.

Conditions

Type 2 Diabetes (T2D)

Keywords

Glucagon-like peptide-1 receptor agonist (GLP-1 RA); FRC (fixed ration combination)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

iGlarLixi (insulin glargine/lixisenatide)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Gla-100 (insulin glargine)

Intervention Type: 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.

Interventions

iGlarLixi (insulin glargine/lixisenatide)

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.

Intervention Type: DRUG

Gla-100 (insulin glargine)

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.

Intervention Type: DRUG

Other Intervention Names

SOLIQUA®; LANTUS®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number: 1560001

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

Phone: 800-633-1610

Email: contact-us@sanofi.com

Other Identifiers

U1111-1306-6660

Identifier Type: REGISTRY

Identifier Source: secondary_id

LPS18034

Identifier Type: -

Identifier Source: org_study_id