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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1306-6660 | Registry Identifier | ICTRP |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iGlarLixi (insulin glargine/lixisenatide) | Experimental | 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. |
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| Gla-100 (insulin glargine) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iGlarLixi (insulin glargine/lixisenatide) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)] | 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 | from baseline to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | contact-us@sanofi.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 1560001 | Recruiting | Beijing | 100730 | China |
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| Label | URL |
|---|---|
| LPS18034 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C479460 | lixisenatide |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study comparing iGlarLixi to Gla-100.
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| Gla-100 (insulin glargine) | Drug | 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. |
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| 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 |
| Change 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 | documented hypoglycemia (defined as ADA Level 1, 2 or 3) | Week 20 |
| Proportion (%) of participants achieving HbA1c <7% without body weight gain | body weight gain (≥5% compared to baseline) | Week 20 |
| Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia and without body weight gain | documented hypoglycemia (defined as ADA Level 1, 2 or 3) | Week 20 |
| Change (mmol/L) in fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG) | from baseline to Week 12 and Week 20 |
| 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 |
| 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 |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |