Clinical trial NCT06671587: iGlarLixi CGM Study in Chinese T2D Individuals After OADs
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes (T2D)
Keywords: Glucagon-like peptide-1 receptor agonist (GLP-1 RA)
FRC (fixed ration combination)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 678
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study comparing iGlarLixi to Gla-100.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)]
timeFrame: from baseline to Week 20
Secondary outcomes:
measure: 2a Proportion (%) of participants achieving TIR target as >70%
timeFrame: Week 20
measure: 2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL)
timeFrame: from baseline to Week 20
measure: 2c Change (mg/dL) in mean daily glucose
timeFrame: from baseline to Week 20
measure: 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)]
timeFrame: Week 20
measure: Change (%) in coefficient of variation (CV)
timeFrame: from baseline to Week 20
measure: Change (%) in the percentage of time in tight range (TITR) [3.9-7.8 mmol/L (70-140 mg/dL)]
timeFrame: from baseline to Week 20
measure: Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50%
timeFrame: Week 20
measure: Proportion (%) of participants achieving ≥5% TIR improvement
timeFrame: from baseline to Week 20
measure: Proportion (%) of participants achieving ≥10% TIR improvement
timeFrame: from baseline to Week 20
measure: Change (%) in TAR >13.9 mmol/L (>250 mg/dL)
timeFrame: from baseline to Week 20
measure: Change (%) in time below range (TBR)
timeFrame: from baseline to Week 20
measure: Change in mean glucose standard deviation (SD)
timeFrame: from baseline to Week 20
measure: Change (%) in glucose management indicator (GMI)
timeFrame: from baseline to Week 20
measure: Proportion (%) of participants achieving CV <36%
timeFrame: Week 20
measure: Proportion (%) of participants achieving CV <32%
timeFrame: Week 20
measure: Change (%) in HbA1c
timeFrame: from baseline to Week 12 and Week 20
measure: Proportion (%) of participants achieving HbA1c <7%
timeFrame: Week 12 and Week 20
measure: Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia
timeFrame: Week 20
measure: Proportion (%) of participants achieving HbA1c <7% without body weight gain
timeFrame: Week 20
measure: Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia and without body weight gain
timeFrame: Week 20
measure: Change (mmol/L) in fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG)
timeFrame: from baseline to Week 12 and Week 20
measure: Change (nmol/L) in fasting C-peptide and post-prandial C-peptide
timeFrame: from baseline to Week 12 and Week 20
measure: Change (U and U/Kg) in insulin dose
timeFrame: from baseline to Week 20
measure: Change (kg) in body weight
timeFrame: from baseline to Week 20
measure: Change (%) in TIR [3.9-10.0 mmol/L (70-180 mg/dL)], TAR [>10.0 mmol/L (>180 mg/dL)] and TBR [3.0 mmol/L (<54 mg/dL)] for specific time blocks (6 am-12 pm, 12 pm-6 pm, 6 pm-12 am, and 12 am-6 am)
timeFrame: from baseline to Week 20
measure: Change in diabetes medication treatment satisfaction scores (total score and by subscales), using the treatment-related impact measure diabetes (TRIM-D) questionnaire
timeFrame: from baseline to Week 20
measure: AE, serious adverse event (SAE), and adverse event of special interest (AESI)
timeFrame: from screening to week 21
measure: Overall hypoglycemia events and rates
timeFrame: from screening to week 21
measure: Nocturnal (00:00 h-05:59 h) hypoglycemia events and rates
timeFrame: from baseline to Week 20
measure: Confirmed hypoglycemia (ADA Level 1, 2 and 3)
timeFrame: from baseline to Week 20
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number: 1560001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: