Trial Outcomes & Findings for Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy (NCT NCT01676220)

Last Updated: 2015-06-24

Results Overview

Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

878 participants

Primary outcome timeframe

Baseline, Month 6

Results posted on

2015-06-24

Participant Flow

A total of 1396 participants were screened, of whom 518 participants were screen failure and 878 participants were randomized.

Participant milestones

Participant milestones
Measure	HOE901-U300 HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus (Insulin Glargine) Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Study STARTED	439	439
Overall Study Treated	435	438
Overall Study Modified Intent-To-Treat Population	432	430
Overall Study COMPLETED	337	314
Overall Study NOT COMPLETED	102	125

Reasons for withdrawal

Reasons for withdrawal
Measure	HOE901-U300 HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus (Insulin Glargine) Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
Overall Study Randomized But Not Treated	4	1
Overall Study Adverse Event	10	8
Overall Study Lack of Efficacy	2	5
Overall Study Protocol Violation	11	12
Overall Study Received Rescue Therapy	14	22
Overall Study Personal Reason	34	45
Overall Study Lost to Follow-up	11	18
Overall Study Selection Criterion/Protocol Violation	9	9
Overall Study Site Closure/Site Withdrawal	1	4
Overall Study Perceived Lack of Efficacy	3	1
Overall Study Non Serious Hypoglycemia	2	0
Overall Study No More Need of Insulin	1	0

Baseline Characteristics

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HOE901-U300 n=439 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=439 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Total n=878 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 9.9 • n=5 Participants	57.2 years STANDARD_DEVIATION 10.3 • n=7 Participants	57.7 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	186 Participants n=5 Participants	185 Participants n=7 Participants	371 Participants n=5 Participants
Sex: Female, Male Male	253 Participants n=5 Participants	254 Participants n=7 Participants	507 Participants n=5 Participants
Body Mass Index (BMI)	32.8 kilogram per square meter STANDARD_DEVIATION 6.9 • n=5 Participants	33.2 kilogram per square meter STANDARD_DEVIATION 6.6 • n=7 Participants	33.0 kilogram per square meter STANDARD_DEVIATION 6.7 • n=5 Participants
Duration of Diabetes	10.11 years STANDARD_DEVIATION 6.49 • n=5 Participants	9.57 years STANDARD_DEVIATION 6.22 • n=7 Participants	9.84 years STANDARD_DEVIATION 6.36 • n=5 Participants
Basal Insulin Daily Dose	0.193 units per kilogram (U/kg) STANDARD_DEVIATION 0.027 • n=5 Participants	0.193 units per kilogram (U/kg) STANDARD_DEVIATION 0.034 • n=7 Participants	0.193 units per kilogram (U/kg) STANDARD_DEVIATION 0.031 • n=5 Participants
Glycated Hemoglobin A1c (HbA1c) Less Than (<) 8%	141 participants n=5 Participants	142 participants n=7 Participants	283 participants n=5 Participants
Glycated Hemoglobin A1c (HbA1c) Greater Than or Equal to (>=) 8%	298 participants n=5 Participants	297 participants n=7 Participants	595 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).

Outcome measures

Outcome measures
Measure	HOE901-U300 n=402 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=394 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Change in HbA1c From Baseline to Month 6 Endpoint	-1.42 percentage of hemoglobin Standard Error 0.047	-1.46 percentage of hemoglobin Standard Error 0.048

SECONDARY outcome

Timeframe: Week 9 Up to Month 6

Population: Modified intent-to-treat population.

Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (\<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \[mg/dL\]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=432 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=430 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6	15.5 percentage of participants	17.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=207 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=222 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint	-2.16 mmol/L Standard Error 0.162	-2.33 mmol/L Standard Error 0.156

SECONDARY outcome

Timeframe: Month 6

Population: mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=422 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=418 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Variability of Preinjection SMPG at Month 6 Endpoint	18.70 percentage of mean Standard Error 0.502	18.33 percentage of mean Standard Error 0.521

SECONDARY outcome

Timeframe: Month 6

Population: mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).

Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=432 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=430 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Percentage of Participants With HbA1c <7% at Month 6	43.1 percentage of participants	42.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).

Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=398 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=387 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint	-3.41 mmol/L Standard Error 0.103	-3.80 mmol/L Standard Error 0.105

SECONDARY outcome

Timeframe: Month 6

Population: mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).

Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=432 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=430 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6	26.2 percentage of participants	29.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).

Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=432 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=430 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 03:00 at Night Plasma Glucose (n=281,277)	-2.63 mmol/L Standard Deviation 3.24	-3.01 mmol/L Standard Deviation 3.75
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Pre-Breakfast Plasma Glucose (n=292,286)	-3.28 mmol/L Standard Deviation 2.72	-3.72 mmol/L Standard Deviation 2.96
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 2 Hours After Breakfast Plasma Glucose (n=278,278)	-3.69 mmol/L Standard Deviation 3.65	-4.08 mmol/L Standard Deviation 4.03
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Pre-Lunch Plasma Glucose (n=289,281)	-2.58 mmol/L Standard Deviation 3.39	-3.39 mmol/L Standard Deviation 3.76
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 2 Hours After Lunch Plasma Glucose (n=280,269)	-2.19 mmol/L Standard Deviation 3.88	-3.13 mmol/L Standard Deviation 3.77
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Pre-Dinner Plasma Glucose (n=291,285)	-2.57 mmol/L Standard Deviation 3.49	-2.43 mmol/L Standard Deviation 3.79
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 2 Hours After Dinner Plasma Glucose (n=282,269)	-2.36 mmol/L Standard Deviation 3.89	-2.33 mmol/L Standard Deviation 4.03
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Bedtime Plasma Glucose (n=249,249)	-2.19 mmol/L Standard Deviation 3.75	-2.26 mmol/L Standard Deviation 3.66

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).

Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=381 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=393 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint	-2.72 mmol/L Standard Error 0.088	-2.90 mmol/L Standard Error 0.089

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).

Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=381 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=393 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint	1.53 percentage of mean Standard Error 0.643	1.41 percentage of mean Standard Error 0.647

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal insulin dose assessment.

Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=362 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=340 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Change in Daily Basal Insulin Dose From Baseline to Month 6	0.43 U/kg Standard Deviation 0.29	0.34 U/kg Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).

DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=371 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=367 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint	4.89 units on a scale Standard Error 0.246	5.12 units on a scale Standard Error 0.251

SECONDARY outcome

Timeframe: Up to 12 months

Population: Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.

Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L).

Outcome measures

Outcome measures
Measure	HOE901-U300 n=435 Participants HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=438 Participants Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Any Hypoglycemia Event: All Hypoglycemia	58.9 percentage of participants	63.2 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Severe Hypoglycemia: All Hypoglycemia	1.4 percentage of participants	2.1 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Documented Symptomatic: All Hypoglycemia	39.1 percentage of participants	44.1 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Asymptomatic: All Hypoglycemia	41.6 percentage of participants	46.8 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Probable Symptomatic: All Hypoglycemia	3.2 percentage of participants	3.0 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Relative: All Hypoglycemia	10.6 percentage of participants	11.6 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Severe and/or Confirmed: All Hypoglycemia	56.3 percentage of participants	61.2 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Any Hypoglycemia Event: Nocturnal Hypoglycemia	27.6 percentage of participants	30.1 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Severe Hypoglycemia: Nocturnal Hypoglycemia	0.0 percentage of participants	0.7 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Documented Symptomatic: Nocturnal Hypoglycemia	18.6 percentage of participants	20.8 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Asymptomatic: Nocturnal Hypoglycemia	13.3 percentage of participants	16.0 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Probable Symptomatic: Nocturnal Hypoglycemia	0.7 percentage of participants	0.0 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Relative: Nocturnal Hypoglycemia	4.4 percentage of participants	3.2 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Severe and/or Confirmed: Nocturnal Hypoglycemia	25.3 percentage of participants	29.5 percentage of participants

Adverse Events

HOE901-U300

Serious events: 35 serious events

Other events: 115 other events

Deaths: 0 deaths

Lantus

Serious events: 39 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	HOE901-U300 n=435 participants at risk HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).	Lantus n=438 participants at risk Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Infections and infestations Nasopharyngitis	9.4% 41/435 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.	10.7% 47/438 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.
Infections and infestations Sinusitis	2.5% 11/435 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.	5.3% 23/438 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.
Infections and infestations Upper respiratory tract infection	10.3% 45/435 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.	7.8% 34/438 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.
Nervous system disorders Headache	8.3% 36/435 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.	5.0% 22/438 • All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first injection of study drug up to 2 day after the last injection of study drug). Analysis was done on safety population.

Additional Information

Trial Transparency Team

Sanofi

Email: Contact [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER