iGlarLixi CGM Study in Chinese T2D Individuals After OADs

Launched by SANOFI · Oct 31, 2024

Keywords

ClinConnect Summary

The iGlarLixi CGM Study is a clinical trial looking at how well a new medication called iGlarLixi helps control blood sugar levels in adults with Type 2 Diabetes (T2D) who have not been able to manage their diabetes with oral medications alone. The study will compare the effects of iGlarLixi to another medication called Gla-100 over a period of 20 weeks. Participants will be randomly assigned to one of these two treatment groups and will have regular visits and phone calls with study staff to monitor their health and the effectiveness of the treatments.

To be eligible for the study, participants must be at least 18 years old, diagnosed with T2D for at least a year, and have been on a stable dose of metformin or another diabetes medication for at least three months. They should also have a specific body weight range and be willing to wear a continuous glucose monitoring device to track their blood sugar levels. Throughout the study, participants can expect around 14 visits, including both in-person appointments and phone calls, to ensure their safety and measure the effectiveness of the treatment.

Gender

ALL

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