Trial Outcomes & Findings for iGlarLixi vs IDegAsp in Chinese Participants After OAD(s) (NCT NCT05413369)
NCT ID: NCT05413369
Last Updated: 2025-09-24
Results Overview
Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
582 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2025-09-24
Participant Flow
The study was conducted at 60 centers in China. A total of 733 participants were screened between 07-Jul-2022 and 17-Apr-2023, of which 151 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.
A total of 582 participants were randomized in a 1:1 ratio to receive either insulin glargine/lixisenatide (iGlarLixi) or insulin degludec and insulin aspart (IDegAsp).
Participant milestones
| Measure |
iGlarLixi
Participants self-administered iGlarLixi (100 units per milliliter \[U/mL\] insulin glargine + 100 or 50 microgram \[mcg\]/mL lixisenatide respectively) subcutaneous (SC) injection once daily on top of metformin +/- sodium-glucose co-transporter 2 inhibitor (SGLT-2i) for 24 weeks. Dose was individually adjusted.
|
IDegAsp
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Overall Study
STARTED
|
291
|
291
|
|
Overall Study
Randomized and Treated
|
290
|
291
|
|
Overall Study
Completed 24-week Treatment Period
|
272
|
284
|
|
Overall Study
COMPLETED
|
274
|
284
|
|
Overall Study
NOT COMPLETED
|
17
|
7
|
Reasons for withdrawal
| Measure |
iGlarLixi
Participants self-administered iGlarLixi (100 units per milliliter \[U/mL\] insulin glargine + 100 or 50 microgram \[mcg\]/mL lixisenatide respectively) subcutaneous (SC) injection once daily on top of metformin +/- sodium-glucose co-transporter 2 inhibitor (SGLT-2i) for 24 weeks. Dose was individually adjusted.
|
IDegAsp
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
4
|
|
Overall Study
Non-compliance with study schedule
|
2
|
1
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Baseline characteristics by cohort
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
Total
n=582 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
291 Participants
n=5 Participants
|
291 Participants
n=7 Participants
|
582 Participants
n=5 Participants
|
|
Glycated Hemoglobin (HbA1c)
|
8.58 percentage of HbA1c
STANDARD_DEVIATION 0.93 • n=5 Participants
|
8.53 percentage of HbA1c
STANDARD_DEVIATION 0.90 • n=7 Participants
|
8.55 percentage of HbA1c
STANDARD_DEVIATION 0.91 • n=5 Participants
|
|
Duration of type 2 diabetes
|
8.56 years
STANDARD_DEVIATION 5.68 • n=5 Participants
|
9.06 years
STANDARD_DEVIATION 6.00 • n=7 Participants
|
8.81 years
STANDARD_DEVIATION 5.84 • n=5 Participants
|
|
Body Mass Index (BMI)
|
25.92 kilograms/square meter (kg/m^2)
STANDARD_DEVIATION 3.47 • n=5 Participants
|
25.42 kilograms/square meter (kg/m^2)
STANDARD_DEVIATION 3.25 • n=7 Participants
|
25.67 kilograms/square meter (kg/m^2)
STANDARD_DEVIATION 3.37 • n=5 Participants
|
|
Randomization stratum of oral antidiabetic (OAD) (s) use at screening
Metformin ± SGLT-2i
|
151 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Randomization stratum of oral antidiabetic (OAD) (s) use at screening
Metformin + other OAD
|
140 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Randomization stratum of oral antidiabetic (OAD) (s) use at screening
Prior use of SGLT-2i
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on all randomized participants.
Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis
|
-1.88 percentage of HbA1c
Standard Error 0.05
|
-1.68 percentage of HbA1c
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on all randomized participants.
Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 24: Superiority Analysis
|
-1.88 percentage of HbA1c
Standard Error 0.05
|
-1.68 percentage of HbA1c
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on all randomized participants.
Body weight was obtained with the participant wearing undergarments or very light clothing and no shoes, and with an empty bladder. The same scale was used throughout the study. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Change in Body Weight From Baseline to Week 24
|
-0.30 kilogram
Standard Error 0.29
|
1.19 kilogram
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed on all randomized participants.
Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c value were considered as non-responders. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c <7% at Week 24
|
72.5 percentage of participants
|
59.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed on all randomized participants.
Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c or body weight value were considered as non-responders. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24
|
40.5 percentage of participants
|
21.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Analysis was performed on all randomized participants.
Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c or body weight value were considered as non-responders. During the study, participants were instructed to document the presence of hypoglycemic episodes in their study diary. Hypoglycemia was characterized as per American Diabetes Association (ADA) 2021 recommendations. * ADA Level 1 hypoglycemia: A measurable glucose concentration \<70 milligram/deciliter (mg/dL) (3.9 millimoles/liter \[mmol/L\]) but \>=54 mg/dL (3.0 mmol/L). * ADA Level 2 hypoglycemia: Blood glucose concentration \<54 mg/dL \[3.0 mmol/L\]; the threshold at which neuroglycopenic symptoms begin to occur and requires immediate action to resolve the hypoglycemic event. * ADA Level 3 hypoglycemia: A severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 and no Hypoglycemia During 24-Week Treatment Period
|
26.5 percentage of participants
|
13.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on all randomized participants.
Blood samples were collected at fasting state (no food or drinks \[except water\] for at least 8 hours) at indicated timepoints. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline to Week 24
|
-3.18 mmol/L
Standard Error 0.11
|
-3.45 mmol/L
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on all randomized participants.
Participants were provided with a glucometer, corresponding supplies, a leaflet, and with diaries in order to perform self-measurement of plasma glucose and its recording and were trained on how to use the glucometer. The 7-point SMPG profile was measured at the following 7-points: pre-prandial (before starting a meal) and 2 hours postprandial each for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. The participants performed 7-point SMPG profile measurement over a single 24-hour period on 2 different days in the week. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 24
|
-3.36 mmol/L
Standard Error 0.12
|
-2.92 mmol/L
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Analysis was performed on all randomized participants.
Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c value were considered as non-responders. Hypoglycemia was characterized as per ADA 2021 recommendations. * ADA Level 1 hypoglycemia: A measurable glucose concentration \<70 mg/dL (3.9 mmol/L) but \>=54 mg/dL (3.0 mmol/L). * ADA Level 2 hypoglycemia: Blood glucose concentration \<54mg/dL \[3.0 mmol/L\]; the threshold at which neuroglycopenic symptoms begin to occur and requires immediate action to resolve the hypoglycemic event. * ADA Level 3 hypoglycemia: A severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c <7% at Week 24 With no Hypoglycemia During 24-Week Treatment Period
|
43.6 percentage of participants
|
35.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Analysis was performed on all randomized participants.
Blood samples were collected at indicated timepoints for analysis of HbA1c. Participants without Week 24 HbA1c value were considered as non-responders. Participants who reached the specified target of HbA1c without any clinically significant symptoms of hypoglycemia as defined in ADA Levels 2 or 3 are reported. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c <7% at Week 24 With no Clinically Relevant Hypoglycemia During 24-Week Treatment Period
|
66.7 percentage of participants
|
56.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Analysis was performed on all randomized participants.
Total daily insulin dose was defined as the sum of the insulin dose from study treatment and non-study treatment (e.g., rescue therapy). It was the average of the last 3 available insulin doses recorded in the electronic case report form in the week before visit.
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Total Daily Insulin Dose at Week 24
|
27.68 units
Standard Error 0.84
|
33.78 units
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: Analysis was performed on all randomized participants.
Routine HbA1c value was used to determine the requirement of rescue medication. Threshold value was HbA1c \>8% at Week 12 or later on despite appropriate corrective actions. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
iGlarLixi
n=291 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Percentage of Participants Who Required Rescue Therapy During the 24-Week Treatment Period
|
5.2 percentage of participants
|
6.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Analysis was performed on all randomized participants. Only those participants with data collected at baseline and Week 24 are reported.
Blood samples were collected at fasting state (no food or drinks \[except water\] for at least 8 hours) at indicated timepoints. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
Outcome measures
| Measure |
iGlarLixi
n=190 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=196 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Change in Fasting C-Peptide From Baseline to Week 24
|
-0.23 nanomoles/liter (nmol/L)
Standard Error 0.02
|
-0.33 nanomoles/liter (nmol/L)
Standard Error 0.02
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 1 day after the last administration of study drug (maximum treatment exposure: 192 days)Population: Analysis was performed on safety population which included all randomized participants who had taken at least 1 dose of study intervention, regardless of the amount of treatment administered.
During the study, participants were instructed to document the presence of hypoglycemic episodes in their study diary. Number of participants who met ADA definition of hypoglycemia during the treatment period are reported. * ADA Level 1 hypoglycemia: A measurable glucose concentration \<70 mg/dL (3.9 mmol/L) but \>=54 mg/dL (3.0 mmol/L). * ADA Level 2 hypoglycemia: Blood glucose concentration \<54mg/dL \[3.0 mmol/L\]; the threshold at which neuroglycopenic symptoms begin to occur and requires immediate action to resolve the hypoglycemic event. * ADA Level 3 hypoglycemia: A severe event characterized by altered mental and/or physical functioning that requires assistance from another person for recovery. The on-treatment period (ie, treatment-emergent \[TE\] period) was defined as the period from the first injection study treatment to the last injection of study treatment + 3 days (1 day for hypoglycemia).
Outcome measures
| Measure |
iGlarLixi
n=290 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Number of Participants With Any Hypoglycemia Event During On-Treatment Period
|
102 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 1 day after the last administration of study drug (maximum treatment exposure: 192 days)Population: Analysis was performed on safety population.
During the study, participants were instructed to document the presence of hypoglycemic episodes in their study diary. Percentage of hypoglycemic events per participant-year during on-treatment period are reported. The on-treatment period (TE period) was defined as the period from the first injection study treatment to the last injection of study treatment + 3 days (1 day for hypoglycemia).
Outcome measures
| Measure |
iGlarLixi
n=290 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Hypoglycemic Event Rate During the On-Treatment Period
|
1.90 event rate per participant-year
|
2.72 event rate per participant-year
|
SECONDARY outcome
Timeframe: From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days)Population: Analysis was performed on the safety population.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any adverse event that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a suspected transmission of any infectious agent via an authorized medicinal product. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. TE period was defined as the period from the first injection study treatment to the last injection of study treatment + 3 days.
Outcome measures
| Measure |
iGlarLixi
n=290 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Adverse Events Of Special Interest (AESIs) and TEAEs Leading to Treatment Discontinuation
Any TEAE
|
220 Participants
|
192 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Adverse Events Of Special Interest (AESIs) and TEAEs Leading to Treatment Discontinuation
Any TESAE
|
15 Participants
|
12 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Adverse Events Of Special Interest (AESIs) and TEAEs Leading to Treatment Discontinuation
Any AESI
|
6 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Adverse Events Of Special Interest (AESIs) and TEAEs Leading to Treatment Discontinuation
Any TEAE leading to treatment discontinuation
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)Population: Analysis was performed on the safety population. Only those participants with data collected for each parameter during TE period are reported.
Vital signs assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) in sitting position with their arm outstretched in line with mid-sternum and supported and weight. Criteria for PCSA: SBP: \<=95 millimeters of mercury (mmHg) and decrease from baseline \>=20 mmHg, \>=160 mmHg and increase from baseline \>=20 mmHg; DBP :\<=45 mmHg and decrease from baseline \>=10 mmHg,\>=110 mmHg and increase from baseline \>=10 mmHg; HR: \<=50 beats/min and decrease from baseline \>=20 beats/min,\>=120 beats/min and increase from baseline \>=20 beats/min; Weight \>=5% decrease from baseline, \>=5% increase from baseline.
Outcome measures
| Measure |
iGlarLixi
n=290 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs
SBP: <=95 mmHg and decrease from baseline >=20 mmHg
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs
SBP: >=160 mmHg and increase from baseline >=20 mmHg
|
4 Participants
|
7 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs
DBP :<=45 mmHg and decrease from baseline >=10 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs
DBP: >=110 mmHg and increase from baseline >=10 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs
HR: <=50 beats/min and decrease from baseline >=20 beats/min
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs
HR: >=120 beats/min and increase from baseline >=20 beats/min
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs
Weight: >=5% decrease from baseline
|
41 Participants
|
19 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs
Weight: >=5% increase from baseline
|
29 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)Population: Analysis was performed on the safety population. Only those participants with data collected for each parameter during TE period are reported.
Criteria for PCSA: For Hemoglobin (Hb), there are 3 criteria: (1)\<=115 grams (g)/L (Male\[M\]) or \<=95 g/L (Female\[F\]), (2)\>= 185 g/L (M) or \>=165 g/L (F), and (3) decrease from baseline \>=20 g/L; Hematocrit: \<=0.37 volume/volume (v/v) (M) or \<=0.32 v/v (F), \>=0.55 v/v (M) or \>=0.5 v/v (F); Red blood cells (RBC): \>=6 Tera/L; Platelets: \<100 Giga/L, \>=700 Giga/L; White blood cells (WBC): \<3.0 Giga/L (Non-Black \[NB\]); \<2.0 Giga/L (Black \[B\]) or \>=16.0 Giga/L; Neutrophils: \<1.5 Giga/L (NB) or \<1.0 Giga/L (B); Lymphocytes: \>4.0 Giga/L; Monocytes: \>0.7 Giga/L; Basophils: \>0.1 Giga/L; Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN \>=0.5 Giga/L).
Outcome measures
| Measure |
iGlarLixi
n=290 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Lymphocytes: > 4.0 Giga/L
|
4 Participants
|
6 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Hb: <=115 g/L (M); <=95 g/L (F)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Hb: >=185 g/L (M); >=165 g/L (F)
|
1 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Hb: Decrease from Baseline >=20 g/L
|
25 Participants
|
19 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F)
|
2 Participants
|
6 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Hematocrit: >=0.55 v/v (M) or >=0.5 v/v (F)
|
37 Participants
|
30 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
RBC: >=6 Tera/L
|
5 Participants
|
6 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Platelets: <100 Giga/L
|
3 Participants
|
7 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Platelets: >=700 Giga/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
WBC: <3.0 Giga/L (NB); < 2.0 Giga/L (B)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
WBC: >=16.0 Giga/L
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B)
|
5 Participants
|
7 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Monocytes: >0.7 Giga/L
|
35 Participants
|
29 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Basophils: >0.1 Giga/L
|
2 Participants
|
5 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology
Eosinophils: >0.5 Giga/L or >ULN
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)Population: Analysis was performed on the safety population. Only those participants with data collected for each parameter during TE period are reported.
Criteria for PCSA: Lipase: \>=3 ULN; Amylase: \>=3 ULN; Sodium: \<=129 mmol/L; \>=160 mmol/L; Potassium: \<3 mmol/L, \>=5.5 mmol/L; Creatinine: \>=150 micromoles per liter (umol/L), \>=30% or \>=100% change from baseline; Glomerular filtration rate (GFR): \>=60-\<90 mL/minute(min)/1.73 square meter (m\^2) (mild decrease in GFR), \>=30-\<60 mL/min/1.73m\^2 (moderate decrease in GFR), \>=15-\<30 mL/min/1.73m\^2 (severe decrease in GFR),\<15 mL/min/1.73m\^2 (end stage renal disease); Creatinine clearance (CG): \>=60-\<90 mL/min (mild decrease in GFR), \>=30-\<60 mL/min (moderate decrease in GFR), \>=15-\<30 mL/min (severe decrease in GFR), \<15 mL/min (end stage renal disease); Urea nitrogen (BUN): \>=17 mmol/L and Uric acid: \<120 or \>408 umol/L; Alanine transaminase (ALT) and aspartate transaminase (AST): \>3/5/10/20 ULN. Alkaline phosphatase:\>1.5 ULN, total bilirubin (TBILI): \>1.5 or \>2 ULN, ALT and TBILI:\> ALT\>3ULN and TBILI \>2 ULN and Conjugated and total bilirubin: \>35% TBILI and TBILI \>1.5 ULN.
Outcome measures
| Measure |
iGlarLixi
n=290 Participants
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 Participants
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Lipase: >=3 ULN
|
6 Participants
|
9 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Amylase: >=3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Sodium: <=129 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Sodium: >=160 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Potassium: <3 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Potassium: >=5.5 mmol/L
|
1 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Creatinine: >=150 umol/L
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Creatinine: >=30% change from baseline
|
36 Participants
|
29 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Creatinine: >=100% change from baseline
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
GFR: Mild decrease in GFR
|
80 Participants
|
79 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
GFR: Moderate decrease in GFR
|
11 Participants
|
11 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
GFR: Severe decrease in GFR
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
GFR: End stage renal disease
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
CG: Mild decrease in GFR
|
80 Participants
|
85 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
CG: Moderate decrease in GFR
|
12 Participants
|
16 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
CG: Severe decrease in GFR
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
CG: End stage renal disease
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
BUN: >=17 mmol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Uric Acid: <120 umol/L
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Uric Acid: >408 umol/L
|
104 Participants
|
108 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
ALT: >3 ULN
|
4 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
ALT: >5 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
ALT: >10 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
ALT: >20 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
AST: >3 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
AST: >5 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
AST: >10 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
AST: >20 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Alkaline Phosphatase: >1.5 ULN
|
2 Participants
|
5 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
TBILI: >1.5 ULN
|
3 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
TBILI: >2 ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
ALT>3ULN and TBILI >2 ULN
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry
Conjugated and TBILI: >35% TBILI and TBILI >1.5 ULN
|
2 Participants
|
0 Participants
|
Adverse Events
iGlarLixi
Serious events: 15 serious events
Other events: 152 other events
Deaths: 0 deaths
IDegAsp
Serious events: 12 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
iGlarLixi
n=290 participants at risk
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 participants at risk
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Pneumonia
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraosseous Lipoma
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Cerebral Infarction
|
0.69%
2/290 • Number of events 2 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Eye disorders
Cataract
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Vascular disorders
Varicophlebitis
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
General disorders
Chest Discomfort
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.34%
1/290 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/290 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.34%
1/291 • Number of events 1 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
Other adverse events
| Measure |
iGlarLixi
n=290 participants at risk
Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
IDegAsp
n=291 participants at risk
Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted.
|
|---|---|---|
|
Infections and infestations
Covid-19
|
13.4%
39/290 • Number of events 39 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
10.7%
31/291 • Number of events 31 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
17.2%
50/290 • Number of events 60 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
12.7%
37/291 • Number of events 42 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.0%
26/290 • Number of events 31 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
8.2%
24/291 • Number of events 27 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Dizziness
|
6.6%
19/290 • Number of events 21 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
1.7%
5/291 • Number of events 5 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
16/290 • Number of events 18 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
2.4%
7/291 • Number of events 8 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Nausea
|
12.1%
35/290 • Number of events 50 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.69%
2/291 • Number of events 3 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
15/290 • Number of events 17 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
0.00%
0/291 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
|
Investigations
Lipase Increased
|
6.6%
19/290 • Number of events 24 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
5.5%
16/291 • Number of events 21 • From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Analysis was performed on the safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER