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New treatment option for Type 2 Diabetes (T2D)
Official title iGlarLixi CGM Study in Chinese T2D Individuals After OADs
ClinicalTrials.gov ID: NCT06671587
What this study is testing
What is iGlarLixi (insulin glargine/lixisenatide)?
iGlarLixi (insulin glargine/lixisenatide) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for type 2 diabetes (t2d).
Also referred to as SOLIQUA®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Participants with severe renal dysfunction
- Participants with short life expectancy
- Participants with conditions/concomitant diseases making them non evaluable for the how well it works 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
See the full eligibility 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
- Participants with severe renal dysfunction
- Participants with short life expectancy
- Participants with conditions/concomitant diseases making them non evaluable for the how well it works 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...
- 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/side effects reasons or lack of how well it works
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.