Type 1 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: * To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: * To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of: * Change of HbA1c from baseline to endpoint (scheduled Month 6) * Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM) * Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia) * Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative) * Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period
Detailed description
The maximum study duration was up to approximately 54 weeks per participants: * Up to 2-week screening period * 6-month open-label comparative efficacy and safety treatment period * 6-month open-label comparative safety extension period * 48-hour post-treatment safety follow-up period
Interventions
DRUGHOE901-U300 (Insulin glargine new formulation)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants with type 1 diabetes mellitus
Exclusion criteria
* HbA1c less than (\<) 7.0% (53 mmol/mol) or greater than (\>) 10% (86 mmol/mol) at screening * Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit * Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit * Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit * Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months * Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening; * Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit * Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change In HbA1c From Baseline to Month 6 Endpoint | Baseline, Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint | Month 6 | — |
| Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint | Baseline, Month 6 | 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. |
| Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint | Baseline, 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. |
| Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint | Baseline, Month 6 | — |
| Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6 | Month 6 | — |
| Percentage of Participants With HbA1c <7% at Month 6 Endpoint | Month 6 | — |
| Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Baseline, Month 6 | 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. |
| Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint | Baseline, Month 6 | — |
| Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint | Baseline, 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. |
| Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Up to Month 12 | 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). |
| Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint | Month 6 | — |
Countries
Canada, Czechia, Denmark, Estonia, Finland, Hungary, Japan, Latvia, Netherlands, Puerto Rico, Romania, Sweden, United States
Participant flow
Recruitment details
A total of 846 participants were screened, of whom 297 participants were screen failure and 549 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| HOE901--U300 HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin. | 274 |
| Lantus Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin. | 275 |
| Total | 549 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 |
| Overall Study | Lack of Efficacy | 5 | 2 |
| Overall Study | Lost to Follow-up | 5 | 0 |
| Overall Study | Nonserious Hypoglycemia | 0 | 3 |
| Overall Study | Perceived Lack of Efficacy | 1 | 1 |
| Overall Study | Personal Reason | 17 | 25 |
| Overall Study | Possibly Hypoglycemia | 1 | 0 |
| Overall Study | Protocol Violation | 13 | 6 |
| Overall Study | Selection Criterion / Protocol Violation | 7 | 5 |
| Overall Study | Serious Adverse Event of Hypoglycemia | 0 | 1 |
| Overall Study | Site Closure / Site Withdrawal | 1 | 3 |
Baseline characteristics
| Characteristic | HOE901--U300 | Lantus | Total |
|---|---|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 13.9 | 48.2 years STANDARD_DEVIATION 13.4 | 47.3 years STANDARD_DEVIATION 13.7 |
| Basal Insulin Daily Dose | 0.381 units per kilogram (U/kg) STANDARD_DEVIATION 0.173 | 0.372 units per kilogram (U/kg) STANDARD_DEVIATION 0.152 | 0.376 units per kilogram (U/kg) STANDARD_DEVIATION 0.162 |
| Body Mass Index (BMI) | 27.6 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.5 | 27.6 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.7 | 27.6 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 5.1 |
| Duration of Diabetes | 20.5 years STANDARD_DEVIATION 12.7 | 21.4 years STANDARD_DEVIATION 13.1 | 21.0 years STANDARD_DEVIATION 12.9 |
| Glycated Hemoglobin (HbA1c) Greater Than or Equal to (>=) 8% | 169 participants | 170 participants | 339 participants |
| Glycated Hemoglobin (HbA1c) Less Than (<) 8% | 105 participants | 105 participants | 210 participants |
| Sex: Female, Male Female | 125 Participants | 111 Participants | 236 Participants |
| Sex: Female, Male Male | 149 Participants | 164 Participants | 313 Participants |
| Total Insulin Daily Dose | 0.714 U/kg STANDARD_DEVIATION 0.278 | 0.724 U/kg STANDARD_DEVIATION 0.245 | 0.719 U/kg STANDARD_DEVIATION 0.262 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 113 / 274 | 86 / 275 |
| serious Total, serious adverse events | 27 / 274 | 26 / 275 |
Outcome results
Primary
Change In HbA1c From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Population: Modified Intent-to-Treat (mITT) 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 Month 6 HbA1c assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HOE901--U300 | Change In HbA1c From Baseline to Month 6 Endpoint | -0.40 percentage of hemoglobin | Standard Error 0.051 |
| Lantus | Change In HbA1c From Baseline to Month 6 Endpoint | -0.44 percentage of hemoglobin | Standard Error 0.051 |
Comparison: Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.95% CI: [-0.098, 0.185]
Secondary
Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
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.
Time frame: Baseline, Month 6
Population: mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HOE901--U300 | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Pre--Lunch (n= 166, 166) | -0.95 mmol/L | Standard Deviation 4.53 |
| HOE901--U300 | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | 2 Hours After Lunch (n= 163,163) | -0.13 mmol/L | Standard Deviation 5.2 |
| HOE901--U300 | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Pre--Breakfast (n= 166, 167) | -0.86 mmol/L | Standard Deviation 5.3 |
| HOE901--U300 | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Pre--Dinner (n= 165,166) | -0.56 mmol/L | Standard Deviation 6 |
| HOE901--U300 | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | 03:00 at Night (n= 156, 159) | -0.47 mmol/L | Standard Deviation 4.56 |
| HOE901--U300 | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | 2 Hours After Dinner (n= 154,152) | -0.93 mmol/L | Standard Deviation 5.27 |
| HOE901--U300 | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | 2 Hours After Breakfast (n= 152, 156) | -0.62 mmol/L | Standard Deviation 4.75 |
| HOE901--U300 | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Bedtime (n= 141,146) | -0.80 mmol/L | Standard Deviation 5.39 |
| Lantus | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Bedtime (n= 141,146) | -1.91 mmol/L | Standard Deviation 5.1 |
| Lantus | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | 03:00 at Night (n= 156, 159) | -0.67 mmol/L | Standard Deviation 4.98 |
| Lantus | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Pre--Breakfast (n= 166, 167) | -0.07 mmol/L | Standard Deviation 5.2 |
| Lantus | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | 2 Hours After Breakfast (n= 152, 156) | -1.18 mmol/L | Standard Deviation 5.66 |
| Lantus | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | 2 Hours After Lunch (n= 163,163) | -1.43 mmol/L | Standard Deviation 5.37 |
| Lantus | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Pre--Dinner (n= 165,166) | -1.74 mmol/L | Standard Deviation 5.28 |
| Lantus | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | 2 Hours After Dinner (n= 154,152) | -1.19 mmol/L | Standard Deviation 5.51 |
| Lantus | Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint | Pre--Lunch (n= 166, 166) | -0.93 mmol/L | Standard Deviation 4.76 |
Secondary
Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint
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.
Time frame: Baseline, Month 6
Population: mITT population. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HOE901--U300 | Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint | -1.16 millimole per liter (mmol/L) | Standard Error 0.223 |
| Lantus | Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint | -0.82 millimole per liter (mmol/L) | Standard Error 0.233 |
Comparison: Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.95% CI: [-0.982, 0.287]
Secondary
Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Population: mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HOE901--U300 | Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint | 0.19 U/kg | Standard Deviation 0.22 |
| Lantus | Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint | 0.10 U/kg | Standard Deviation 0.16 |
Secondary
Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Population: mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HOE901--U300 | Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint | -0.95 mmol/L | Standard Error 0.263 |
| Lantus | Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint | -1.14 mmol/L | Standard Error 0.26 |
Secondary
Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
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.
Time frame: Baseline, Month 6
Population: mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HOE901--U300 | Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint | 1.00 units on a scale | Standard Error 0.331 |
| Lantus | Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint | 1.41 units on a scale | Standard Error 0.334 |
Secondary
Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint
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.
Time frame: Baseline, Month 6
Population: mITT population. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HOE901--U300 | Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint | -3.03 percentage of mean | Standard Error 1.573 |
| Lantus | Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint | -1.76 percentage of mean | Standard Error 1.651 |
Secondary
Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6
Time frame: Month 6
Population: mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HOE901--U300 | Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6 | 9.9 percentage of participants |
| Lantus | Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6 | 12.8 percentage of participants |
Secondary
Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint
Time frame: Month 6
Population: mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HOE901--U300 | Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint | 25.3 percentage of participants |
| Lantus | Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint | 25.6 percentage of participants |
Secondary
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Time frame: Month 6
Population: mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HOE901--U300 | Percentage of Participants With HbA1c <7% at Month 6 Endpoint | 16.8 percentage of participants |
| Lantus | Percentage of Participants With HbA1c <7% at Month 6 Endpoint | 15.0 percentage of participants |
Secondary
Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint
Time frame: Month 6
Population: mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HOE901--U300 | Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint | 8.1 percentage of participants |
| Lantus | Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint | 5.5 percentage of participants |
Secondary
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Any Hypoglycemia Event: All Hypoglycemia | 95.3 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Severe Hypoglycemia: All Hypoglycemia | 9.1 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Documented Symptomatic: All Hypoglycemia | 87.6 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Asymptomatic: All Hypoglycemia | 76.6 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Probable Symptomatic: All Hypoglycemia | 11.3 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Relative: All Hypoglycemia | 14.6 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Severe and/or Confirmed: All Hypoglycemia | 94.9 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Any Hypoglycemia Event: Nocturnal Hypoglycemia | 73.4 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Severe Hypoglycemia: Nocturnal Hypoglycemia | 3.3 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Documented Symptomatic: Nocturnal Hypoglycemia | 64.2 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Asymptomatic: Nocturnal Hypoglycemia | 35.0 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Probable Symptomatic: Nocturnal Hypoglycemia | 5.1 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Relative: Nocturnal Hypoglycemia | 4.0 percentage of participants |
| HOE901--U300 | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Severe and/or Confirmed: Nocturnal Hypoglycemia | 72.6 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Asymptomatic: Nocturnal Hypoglycemia | 38.9 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Any Hypoglycemia Event: All Hypoglycemia | 94.9 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Any Hypoglycemia Event: Nocturnal Hypoglycemia | 74.9 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Severe Hypoglycemia: All Hypoglycemia | 11.3 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Relative: Nocturnal Hypoglycemia | 5.5 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Documented Symptomatic: All Hypoglycemia | 86.5 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Severe Hypoglycemia: Nocturnal Hypoglycemia | 3.3 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Asymptomatic: All Hypoglycemia | 81.5 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Probable Symptomatic: Nocturnal Hypoglycemia | 6.5 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Probable Symptomatic: All Hypoglycemia | 15.3 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Documented Symptomatic: Nocturnal Hypoglycemia | 63.3 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Relative: All Hypoglycemia | 9.5 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Severe and/or Confirmed: Nocturnal Hypoglycemia | 74.5 percentage of participants |
| Lantus | Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 | Severe and/or Confirmed: All Hypoglycemia | 94.5 percentage of participants |