iGlarLixi CGM Study in Chinese T2D Individuals After OADs

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)] [Срок оценки: from baseline to Week 20]

Вторичные конечные точки (12)

• 2a Proportion (%) of participants achieving TIR target as >70% [Срок оценки: Week 20]
• 2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL) [Срок оценки: from baseline to Week 20]
• 2c Change (mg/dL) in mean daily glucose [Срок оценки: from baseline to Week 20]
• 2d Proportion (%) of participants achieving composite target of TIR as >70% [3.9-10.0 mmol/L (70-180 mg/dL)] with TAR as <25% [>10.0 mmol/L (>180 mg/dL)] with TBR as <4% [<3.9 mmol/L (<70 m)/dL)] [Срок оценки: Week 20]
• Change (%) in coefficient of variation (CV) [Срок оценки: from baseline to Week 20]
• Change (%) in the percentage of time in tight range (TITR) [3.9-7.8 mmol/L (70-140 mg/dL)] [Срок оценки: from baseline to Week 20]
• Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50% [Срок оценки: Week 20]
• Proportion (%) of participants achieving ≥5% TIR improvement [Срок оценки: from baseline to Week 20]
• Proportion (%) of participants achieving ≥10% TIR improvement [Срок оценки: from baseline to Week 20]
• Change (%) in TAR >13.9 mmol/L (>250 mg/dL) [Срок оценки: from baseline to Week 20]
• Change (%) in time below range (TBR) [Срок оценки: from baseline to Week 20]
• Change in mean glucose standard deviation (SD) [Срок оценки: from baseline to Week 20]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Investigational Site Number: 1560001 — Пекин

Идентификаторы

NCT: NCT06671587 · LPS18034 · U1111-1306-6660

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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