A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Me… (NCT06716424) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus
India105 participantsStarted 2025-01-06
Plain-language summary
This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be ≥18 years of age, at the time of signing the informed consent
* Participants with Type 2 Diabetes diagnosed for at least 1 year at the time of screening on treatment with Metformin +/- OADs or basal insulin/GLP-1RA for a minimum period of 6 months prior to screening
* HbA1c between ≥ 7.5% and ≤10.5% inclusive, during screening
* Participant with BMI \>= 25 kg/m2 (as per Endocrine Society of India, Ref 12)
* Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (i.e., until Week 27)
* Signed informed consent
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Type 1 Diabetes mellitus or any diabetes other than T2DM
* Prior use of any combination of Basal Insulin + GLP-1 RA Fixed Ratio or Free Combination, Premix Insulin, Basal bolus therapy
* Basal insulin dose \>50 U at screening
* Any clinically-significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the Investigator would preclude safe completion of the…
What they're measuring
1
Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)