iGlarLixi CGM Study in Chinese T2D Individuals After OADs

Phase 4RecruitingNCT06671587

Sanofi678 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

678

Interventions

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: from baseline to Week 20

Secondary Outcomes

2a Proportion (%) of participants achieving TIR target as >70%

Time frame: Week 20

2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL)

Time frame: from baseline to Week 20

2c Change (mg/dL) in mean daily glucose

Time frame: 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)]

Time frame: Week 20

Change (%) in coefficient of variation (CV)

Time frame: 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)]

Time frame: from baseline to Week 20

Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50%

Time frame: Week 20

Proportion (%) of participants achieving ≥5% TIR improvement

Time frame: from baseline to Week 20

Proportion (%) of participants achieving ≥10% TIR improvement

Time frame: from baseline to Week 20

Change (%) in TAR >13.9 mmol/L (>250 mg/dL)

Time frame: from baseline to Week 20

Change (%) in time below range (TBR)

* \<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) time

Time frame: from baseline to Week 20

Change in mean glucose standard deviation (SD)

Time frame: from baseline to Week 20

Change (%) in glucose management indicator (GMI)

Time frame: from baseline to Week 20

Proportion (%) of participants achieving CV <36%

Time frame: Week 20

Proportion (%) of participants achieving CV <32%

Time frame: Week 20

Change (%) in HbA1c

Time frame: from baseline to Week 12 and Week 20

Proportion (%) of participants achieving HbA1c <7%

Time frame: Week 12 and Week 20

Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia

documented hypoglycemia (defined as ADA Level 1, 2 or 3)

Time frame: Week 20

Proportion (%) of participants achieving HbA1c <7% without body weight gain

body weight gain (≥5% compared to baseline)

Time frame: 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)

Time frame: Week 20

Change (mmol/L) in fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG)

Time frame: from baseline to Week 12 and Week 20

Change (nmol/L) in fasting C-peptide and post-prandial C-peptide

Time frame: from baseline to Week 12 and Week 20

Change (U and U/Kg) in insulin dose

Time frame: from baseline to Week 20

Change (kg) in body weight

Time frame: 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)

Time frame: 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

Time frame: from baseline to Week 20

AE, serious adverse event (SAE), and adverse event of special interest (AESI)

Time frame: from screening to week 21

Overall hypoglycemia events and rates

Time frame: from screening to week 21

Nocturnal (00:00 h-05:59 h) hypoglycemia events and rates

Time frame: from baseline to Week 20

Confirmed hypoglycemia (ADA Level 1, 2 and 3)

* 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

Time frame: from baseline to Week 20

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts