Trial Outcomes & Findings for Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin (NCT NCT01499082)

NCT ID: NCT01499082

Last Updated: 2022-03-25

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

807 participants

Primary outcome timeframe

Baseline, Month 6

Results posted on

2022-03-25

Participant Flow

A total of 1177 participants were screened, of whom 370 participants were screen failure and 807 participants were randomized.

Following the main 6 month treatment period, eligible participants previously using HOE901-U300 were randomized (1:1) in a substudy and continued with fixed-dosing (every 24 hours) or started a adaptable-dosing (at intervals of 24 +/- 3 hours) regimen for 3 Months (Month 6 to 9).

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 on top of mealtime insulin analogue.	Lantus Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.
Overall Study STARTED	404	403
Overall Study Treated	404	402
Overall Study Participated in Substudy	109	0
Overall Study Modified Intent-to-Treat Population	404	400
Overall Study COMPLETED	359	355
Overall Study NOT COMPLETED	45	48

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 on top of mealtime insulin analogue.	Lantus Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.
Overall Study Randomized but not Treated	0	1
Overall Study Adverse Event	12	16
Overall Study Lack of Efficacy	1	1
Overall Study Protocol Violation	6	8
Overall Study Diverse Reasons	18	14
Overall Study Site Closure for Noncompliance	5	2
Overall Study Hypoglycemia	2	3
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HOE901-U300 n=404 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=403 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.	Total n=807 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 8.5 • n=5 Participants	59.8 years STANDARD_DEVIATION 8.7 • n=7 Participants	60.0 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	187 Participants n=5 Participants	193 Participants n=7 Participants	380 Participants n=5 Participants
Sex: Female, Male Male	217 Participants n=5 Participants	210 Participants n=7 Participants	427 Participants n=5 Participants
Body Mass Index (BMI)	36.6 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.8 • n=5 Participants	36.6 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.1 • n=7 Participants	36.6 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 6.4 • n=5 Participants
Duration of Diabetes	15.6 years STANDARD_DEVIATION 7.2 • n=5 Participants	16.1 years STANDARD_DEVIATION 7.8 • n=7 Participants	15.8 years STANDARD_DEVIATION 7.5 • n=5 Participants
Basal Insulin Daily Dose	0.668 units per kilogram (U/kg) STANDARD_DEVIATION 0.263 • n=5 Participants	0.667 units per kilogram (U/kg) STANDARD_DEVIATION 0.241 • n=7 Participants	0.668 units per kilogram (U/kg) STANDARD_DEVIATION 0.252 • n=5 Participants
Total Insulin Daily Dose	1.194 U/kg STANDARD_DEVIATION 0.483 • n=5 Participants	1.200 U/kg STANDARD_DEVIATION 0.448 • n=7 Participants	1.197 U/kg STANDARD_DEVIATION 0.466 • n=5 Participants
Glycated Hemoglobin A1c (HbA1c) Less Than (<) 8%	144 participants n=5 Participants	144 participants n=7 Participants	288 participants n=5 Participants
Glycated Hemoglobin A1c (HbA1c) Greater Than or Equal to (>=) 8%	260 participants n=5 Participants	259 participants n=7 Participants	519 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Modified Intent-to-Treat population: all randomized participants who received at least (\>=)1 dose, had baseline and \>=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=391 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=394 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Change in HbA1c From Baseline to Month 6 Endpoint	-0.83 percentage of hemoglobin Standard Error 0.060	-0.83 percentage of hemoglobin Standard Error 0.061

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 \[mg/dL\]).

Outcome measures

Outcome measures
Measure	HOE901-U300 n=404 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=400 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint	36.1 percentage of participants	46.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.

Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=365 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=360 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint	-0.90 mmol/L Standard Error 0.182	-0.84 mmol/L Standard Error 0.182

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.

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.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=365 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=360 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint	-1.10 percentage of mean Standard Error 1.222	-1.08 percentage of mean Standard Error 1.222

SECONDARY outcome

Timeframe: Month 6

Population: mITT Population. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=391 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=394 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Percentage of Participants With HbA1c <7% at Month 6 Endpoint	39.6 percentage of participants	40.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=376 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=385 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint	-1.29 mmol/L Standard Error 0.191	-1.38 mmol/L Standard Error 0.192

SECONDARY outcome

Timeframe: Month 6

Population: mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=389 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=392 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint	26.5 percentage of participants	23.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point. Missing data imputed using last observation carried forward.

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.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=404 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=400 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint 03:00 at Night Plasma Glucose (n=333,323)	-0.98 mmol/L Standard Error 0.248	-1.16 mmol/L Standard Error 0.251
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint Pre-Breakfast Plasma Glucose (n=343,333)	-1.19 mmol/L Standard Error 0.189	-1.49 mmol/L Standard Error 0.190
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint 2 Hours After Breakfast Plasma Glucose (n=335,326)	-1.60 mmol/L Standard Error 0.241	-1.90 mmol/L Standard Error 0.243
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint Pre-Lunch Plasma Glucose (n=337,331)	-1.05 mmol/L Standard Error 0.213	-1.23 mmol/L Standard Error 0.216
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint 2 Hours After Lunch Plasma Glucose (n=336,325)	-0.64 mmol/L Standard Error 0.280	-0.63 mmol/L Standard Error 0.282
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint Pre-Dinner Plasma Glucose (n=338,333)	-0.47 mmol/L Standard Error 0.261	-0.37 mmol/L Standard Error 0.260
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint 2 Hours After Dinner Plasma Glucose (n=331,327)	-0.96 mmol/L Standard Error 0.298	-1.17 mmol/L Standard Error 0.298
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint Bedtime Plasma Glucose (n=324, 325)	-0.88 mmol/L Standard Error 0.324	-0.91 mmol/L Standard Error 0.326

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=403 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=400 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint	0.28 U/kg Standard Error 0.017	0.19 U/kg Standard Error 0.017

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.

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.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=366 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=363 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint	2.32 units on a scale Standard Error 0.310	2.24 units on a scale Standard Error 0.313

SECONDARY outcome

Timeframe: Up to Month 12

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=404 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=402 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Probable Symptomatic: All Hypoglycemia	5.7 percentage of participants	8.5 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Any Hypoglycemia Event: All Hypoglycemia	87.4 percentage of participants	92.0 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Severe Hypoglycemia: All Hypoglycemia	6.7 percentage of participants	7.5 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Documented Symptomatic: All Hypoglycemia	74.8 percentage of participants	82.8 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Asymptomatic: All Hypoglycemia	70.5 percentage of participants	73.4 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Relative: All Hypoglycemia	15.8 percentage of participants	21.1 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Severe and/or Confirmed: All Hypoglycemia	85.9 percentage of participants	91.5 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Any Hypoglycemia Event: Nocturnal Hypoglycemia	55.4 percentage of participants	66.2 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Severe Hypoglycemia: Nocturnal	2.5 percentage of participants	3.2 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Documented Symptomatic: Nocturnal Hypoglycemia	44.6 percentage of participants	57.2 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Asymptomatic: Nocturnal Hypoglycemia	29.2 percentage of participants	31.1 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Probable Symptomatic: Nocturnal Hypoglycemia	2.2 percentage of participants	2.7 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Relative: Nocturnal Hypoglycemia	5.0 percentage of participants	10.0 percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Severe and/or Confirmed: Nocturnal Hypoglycemia	54.5 percentage of participants	64.7 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6 Up to Month 9

Population: mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants enrolled in the substudy and who were receiving HOE901-U300 (Adaptable dosing intervals or Fixed dosing intervals).

Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months.

Outcome measures

Outcome measures
Measure	HOE901-U300 n=55 Participants HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=51 Participants Lantus SC injection once daily for 12 months on top of mealtime insulin.
Change in HbA1c From Month 6 to Month 9	0.21 percentage of hemoglobin Standard Error 0.111	0.15 percentage of hemoglobin Standard Error 0.120

Adverse Events

HOE901-U300

Serious events: 53 serious events

Other events: 131 other events

Deaths: 0 deaths

Lantus

Serious events: 62 serious events

Other events: 132 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	HOE901-U300 n=404 participants at risk HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.	Lantus n=402 participants at risk Lantus SC injection once daily for 12 months on top of mealtime insulin.
Gastrointestinal disorders Diarrhoea	5.4% 22/404 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.	5.2% 21/402 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.
Infections and infestations Bronchitis	5.7% 23/404 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.	7.5% 30/402 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.
Infections and infestations Influenza	5.4% 22/404 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.	4.5% 18/402 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.
Infections and infestations Nasopharyngitis	8.4% 34/404 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.	9.0% 36/402 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.
Infections and infestations Sinusitis	5.2% 21/404 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.	3.7% 15/402 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.
Infections and infestations Upper respiratory tract infection	9.4% 38/404 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.	8.5% 34/402 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 13/404 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.	5.2% 21/402 • All Adverse Events (AE) were collected from signature of the informed consent form up to 12 months regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of study drug up to 2 days (1 day for FPG, SMPG; 0 day for insulin glargine dose) after the last injection of study drug). Analysis was done on safety population.

Additional Information

Trial Transparency Team

Sanofi

Email: [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