Trial Outcomes & Findings for Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents (NCT NCT03434119)

NCT ID: NCT03434119

Last Updated: 2022-03-28

Results Overview

Change in HbA1c was calculated by subtracting baseline value from Week 26 value.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 241 participants
• Primary outcome timeframe: Baseline, Week 26
• Results posted on: 2022-03-28

Participant Flow

The study was conducted at 94 sites in United States (US). A total of 534 participants were screened between 20 February 2018 and 01 November 2018, of which 293 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level less than (<)7.5% or greater than (>)10% at the screening visit.

Randomization was stratified by self-reported ethnic/racial group, screening HbA1c values (<8.5% vs >=8.5%), background use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors (yes/no), background use of sulfonylureas (yes/no). Assignment to arms was done centrally by an interactive response technology (IRT) in 1:1 ratio (Soliqua 100/33:Lantus).

Participant milestones

Measure	Soliqua 100/33 Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.	Lantus Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Overall Study STARTED	116	125
Overall Study Treated	115	125
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	107	113

Reasons for withdrawal

Measure	Soliqua 100/33 Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.	Lantus Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Overall Study Randomized but not treated	1	0
Overall Study Adverse Event	1	0
Overall Study Poor Compliance to Protocol	0	1
Overall Study Study Terminated by Sponsor	91	102
Overall Study Withdrawal by Subject	7	5
Overall Study Other than specified	7	5

Baseline Characteristics

Number of participants analyzed = participants with available data for specified measure.

Baseline characteristics by cohort

Measure	Soliqua 100/33 n=116 Participants Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.	Lantus n=125 Participants Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.	Total n=241 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 9.7 • n=116 Participants	57.7 years STANDARD_DEVIATION 11.9 • n=125 Participants	59.6 years STANDARD_DEVIATION 11.1 • n=241 Participants
Sex: Female, Male Female	57 Participants n=116 Participants	67 Participants n=125 Participants	124 Participants n=241 Participants
Sex: Female, Male Male	59 Participants n=116 Participants	58 Participants n=125 Participants	117 Participants n=241 Participants
Race/Ethnicity, Customized Hispanics of any race	60 Participants n=116 Participants	64 Participants n=125 Participants	124 Participants n=241 Participants
Race/Ethnicity, Customized Non-Hispanic black or African Americans	39 Participants n=116 Participants	40 Participants n=125 Participants	79 Participants n=241 Participants
Race/Ethnicity, Customized Non-Hispanic Asians	17 Participants n=116 Participants	21 Participants n=125 Participants	38 Participants n=241 Participants
Body Mass Index (BMI)	30.90 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.74 • n=116 Participants	30.67 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.93 • n=125 Participants	30.78 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.83 • n=241 Participants
Duration of Diabetes <10 years	26 Participants n=116 Participants	39 Participants n=125 Participants	65 Participants n=241 Participants
Duration of Diabetes >=10 years	90 Participants n=116 Participants	86 Participants n=125 Participants	176 Participants n=241 Participants
Glycated Haemoglobin (HbA1c %)	8.62 percentage of hemoglobin STANDARD_DEVIATION 0.74 • n=114 Participants • Number of participants analyzed = participants with available data for specified measure.	8.62 percentage of hemoglobin STANDARD_DEVIATION 0.68 • n=125 Participants • Number of participants analyzed = participants with available data for specified measure.	8.62 percentage of hemoglobin STANDARD_DEVIATION 0.71 • n=239 Participants • Number of participants analyzed = participants with available data for specified measure.
Body Weight	84.97 kilograms (kg) STANDARD_DEVIATION 15.89 • n=116 Participants	84.84 kilograms (kg) STANDARD_DEVIATION 19.34 • n=125 Participants	84.90 kilograms (kg) STANDARD_DEVIATION 17.73 • n=241 Participants

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: Analysis was performed on intent-to-treat (ITT) population that included all randomized participants. Here, overall number of participants analyzed = participants with available data for the specified outcome measure.

Change in HbA1c was calculated by subtracting baseline value from Week 26 value.

Outcome measures

Measure	Soliqua 100/33 n=19 Participants Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.	Lantus n=26 Participants Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26	-1.86 percentage of HbA1c Standard Deviation 0.96	-1.07 percentage of HbA1c Standard Deviation 1.17

SECONDARY outcome

Timeframe: Week 26

Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for the specified outcome measure.

Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.

Outcome measures

Measure	Soliqua 100/33 n=19 Participants Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.	Lantus n=26 Participants Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Percentage of Participants Achieving HbA1c Target of <7% at Week 26	52.6 percentage of participants	30.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Data were not collected, hence planned analysis was not performed due to early termination of the study.

The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Data were not collected, hence planned analysis was not performed due to early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.

Change in daily dose was calculated by subtracting baseline value from Week 26 value.

Outcome measures

Measure	Soliqua 100/33 n=9 Participants Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.	Lantus n=11 Participants Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Change From Baseline in Daily Insulin Glargine Dose at Week 26	18.7 International Units (IU) Standard Deviation 16.4	14.1 International Units (IU) Standard Deviation 16.5

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.

Change in body weight was calculated by subtracting baseline value from Week 26 value.

Outcome measures

Measure	Soliqua 100/33 n=18 Participants Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.	Lantus n=24 Participants Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Change From Baseline in Body Weight at Week 26	1.69 kilograms (kg) Standard Deviation 3.74	1.52 kilograms (kg) Standard Deviation 2.92

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: Analysis was performed on safety population that included all randomized participants who received at least 1 dose of open-label investigational medicinal product (IMP), regardless of the amount of treatment administered. Participants were analyzed according to the treatment actually received.

Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of <=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose <=70 mg/dL (3.9 mmol/L) and excluding plasma glucose <54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of <54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose <54 mg/dL (3.0 mmol/L) regardless of symptoms.

Outcome measures

Measure	Soliqua 100/33 n=115 Participants Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.	Lantus n=125 Participants Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period Any hypoglycemia	48.7 percentage of participants	52.8 percentage of participants
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period Severe hypoglycemia	1.7 percentage of participants	2.4 percentage of participants
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period Documented hypoglycaemia <=70 mg/dL (3.9 mmol/L)	43.5 percentage of participants	48.8 percentage of participants
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period Documented hypoglycaemia <54 mg/dL (3.0 mmol/L)	12.2 percentage of participants	18.4 percentage of participants

Adverse Events

Soliqua 100/33

Serious events: 7 serious events

Other events: 21 other events

Deaths: 0 deaths

Lantus

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Soliqua 100/33 n=115 participants at risk Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.	Lantus n=125 participants at risk Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/115 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.80% 1/125 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Cardiac disorders Acute Myocardial Infarction	0.87% 1/115 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.00% 0/125 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Cardiac disorders Angina Unstable	0.00% 0/115 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.80% 1/125 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Cardiac disorders Atrial Fibrillation	0.87% 1/115 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.00% 0/125 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Cardiac disorders Cardiac Failure Congestive	0.87% 1/115 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.00% 0/125 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Cardiac disorders Coronary Artery Disease	0.87% 1/115 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.00% 0/125 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Cardiac disorders Myocardial Infarction	0.87% 1/115 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.00% 0/125 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/115 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.80% 1/125 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Infections and infestations Gastroenteritis Viral	0.00% 0/115 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.80% 1/125 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Metabolism and nutrition disorders Hypoglycaemia	0.87% 1/115 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.00% 0/125 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.87% 1/115 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.00% 0/125 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Nervous system disorders Facial Paralysis	0.87% 1/115 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.00% 0/125 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Nervous system disorders Hypoglycaemic Unconsciousness	0.00% 0/115 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.80% 1/125 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Psychiatric disorders Alcohol Withdrawal Syndrome	0.00% 0/115 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.80% 1/125 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/115 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	0.80% 1/125 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.

Other adverse events

Measure	Soliqua 100/33 n=115 participants at risk Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks.	Lantus n=125 participants at risk Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Gastrointestinal disorders Diarrhoea	7.0% 8/115 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	2.4% 3/125 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Gastrointestinal disorders Nausea	7.0% 8/115 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	1.6% 2/125 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Gastrointestinal disorders Vomiting	5.2% 6/115 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	1.6% 2/125 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	2.6% 3/115 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	8.0% 10/125 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
Nervous system disorders Headache	6.1% 7/115 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.	6.4% 8/125 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (maximum treatment exposure: 194 days) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent AEs that is AEs that developed/worsened or became serious and deaths that occurred during the 'on treatment period' (the time from the first injection of IMP up to 3 days after the last injection of IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: Contact-US@sanofi.com

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