iGlarLixi CGM Study in Chinese T2D Individuals After OADs
- Conditions
- Type 2 Diabetes (T2D)
- Interventions
- Drug: iGlarLixi (insulin glargine/lixisenatide)Drug: Gla-100 (insulin glargine)
- Registration Number
- NCT06671587
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 678
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iGlarLixi (insulin glargine/lixisenatide) iGlarLixi (insulin glargine/lixisenatide) Participants will receive iGlarLixi once daily for 20 weeks. iGlarLixi is to be initiated with the starting daily dose of 5-10 dose steps on Visit 4 (Day 1) and will be titrated according to fasting SMBG to achieve glycemic target of ≥80 and ≤110 mg/dL. Gla-100 (insulin glargine) Gla-100 (insulin glargine) Participants will receive Gla-100 once daily for 20 weeks. Gla-100 is to be initiated with the starting daily dose of 5-10 U on Visit 4 (Day 1) and will be titrated according to fasting SMBG to achieve and maintain same glycemic target of ≥80 and ≤110 mg/dL.
- Primary Outcome Measures
Name Time Method Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)] from baseline to Week 20 Superiority of mean change in the percentage of TIR \[3.9-10.0 mmol/L (70-180 mg/dL)\] from baseline to Week 20 of iGlarLixi vs Gla-100
- Secondary Outcome Measures
Name Time Method Change (nmol/L) in fasting C-peptide and post-prandial C-peptide from baseline to Week 12 and Week 20 Change (U and U/Kg) in insulin dose from baseline to Week 20 Change (kg) in body weight from baseline to Week 20 2a Proportion (%) of participants achieving TIR target as >70% Week 20 2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL) from baseline to Week 20 2c Change (mg/dL) in mean daily glucose 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)] Week 20 Change (%) in coefficient of variation (CV) 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)] from baseline to Week 20 Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50% Week 20 Proportion (%) of participants achieving ≥5% TIR improvement from baseline to Week 20 Proportion (%) of participants achieving ≥10% TIR improvement from baseline to Week 20 Change (%) in TAR >13.9 mmol/L (>250 mg/dL) from baseline to Week 20 Change (%) in time below range (TBR) from baseline to Week 20 * \<3.9 mmol/L (\<70 mg/dL), including \<3.0 mmol/L (\<54 mg/dL)
* \<3.0 mmol/L (\<54 mg/dL)
* \<3.9 mmol/L (\<70 mg/dL), including \<3.0 mmol/L (\<54 mg/dL) in nocturnal (00:00 h-05:59 h) time
* \<3.0 mmol/L (\<54 mg/dL) in nocturnal (00:00 h-05:59 h) timeChange in mean glucose standard deviation (SD) from baseline to Week 20 Change (%) in glucose management indicator (GMI) from baseline to Week 20 Proportion (%) of participants achieving CV <36% Week 20 Proportion (%) of participants achieving CV <32% Week 20 Change (%) in HbA1c from baseline to Week 12 and Week 20 Proportion (%) of participants achieving HbA1c <7% Week 12 and Week 20 Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia Week 20 documented hypoglycemia (defined as ADA Level 1, 2 or 3)
Proportion (%) of participants achieving HbA1c <7% without body weight gain Week 20 body weight gain (≥5% compared to baseline)
Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia and without body weight gain Week 20 documented hypoglycemia (defined as ADA Level 1, 2 or 3)
Change (mmol/L) in fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG) from baseline to Week 12 and Week 20 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) from baseline to Week 20 Change in diabetes medication treatment satisfaction scores (total score and by subscales), using the treatment-related impact measure diabetes (TRIM-D) questionnaire from baseline to Week 20 AE, serious adverse event (SAE), and adverse event of special interest (AESI) from screening to week 21 Overall hypoglycemia events and rates from screening to week 21 Nocturnal (00:00 h-05:59 h) hypoglycemia events and rates from baseline to Week 20 Confirmed hypoglycemia (ADA Level 1, 2 and 3) from baseline to Week 20 * ADA Level 1: Measurable glucose concentration \<70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L)
* ADA Level 2: Measurable glucose concentration \<54 mg/dL (3.0 mmol/L) that needs immediate action
* ADA Level 3: Severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery
Trial Locations
- Locations (1)
Investigational Site Number: 1560001
🇨🇳Beijing, China