iGlarLixi CGM Study in Chinese T2D Individuals After OADs
ConditionType 2 Diabetes (T2D)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanofi
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
iGlarLixi (insulin glargine/lixisenatide)
DrugiGlarLixi 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)
DrugGla-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.
Treatment groups
678 Participants
are divided into 2 treatment groupsGroup A: iGlarLixi (insulin glargine/lixisenatide)Experimental treatment 1 intervention
Group B: Gla-100 (insulin glargine)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 20Secondary outcomes
1
2a Proportion (%) of participants achieving TIR target as >70%
Time frame
Week 202
2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL)
Time frame
from baseline to Week 203
2c Change (mg/dL) in mean daily glucose
Time frame
from baseline to Week 204
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 Source ClinicalTrials.gov