Type 1 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study. To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension. To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (\<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.
Detailed description
The study consisted of a: * Up to 2 weeks screening period * 26-week treatment period * 26-week comparative safety extension period * 1-day follow-up period * The maximum study duration would be 54 weeks per participant and a 1-day safety follow-up
Interventions
DRUGSAR342434
SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by deep subcutaneous (SC) injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour post prandial plasma glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.
DRUGHumalog
Humalog 100 U/mL (dose range of 1 unit to 60 units) self-administered by deep SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycaemia.
Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.
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
* Participants with T1DM diagnosed for at least 12 months and had been treated with insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit. * Written informed consent.
Exclusion criteria
* At screening visit, age under legal age of adulthood. * HbA1c \<7.0% or \>10% at screening. * Diabetes other than T1DM. * Status post pancreatectomy. * Status post pancreas and/or islet cell transplantation. * Pregnancy and lactation. * Women of childbearing potential not protected by highly effective contraceptive method of birth control. * Less than 1 year on continuous insulin treatment. * Use of insulin pump in the last 6 months before screening visit. * Use of glucose lowering treatments other than insulin including non-insulin injectable peptides in the last 6 months prior to screening visit. * Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before screening visit. Liprolog® is a European Union approved insulin lispro and is allowed in those countries where it is marketed. * 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 (eg, 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 | Description |
|---|---|---|
| Change in HbA1c From Baseline to Week 26 | Baseline, Week 26 | Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HbA1c <7.0% at Week 26 | Week 26 | Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders. |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 | Baseline, Week 26 | Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26. |
| Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26 | Baseline, Week 26 | Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26. |
| Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days) | Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. 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 symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (\<3.0 mmol/L) were also analyzed. |
| Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days) | Percentage of participants with hypersensitivity reactions and injection site reactions were reported. |
| Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs) | First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days) | Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA). |
| Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 | Baseline, Week 26 | Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Baseline, Week 26, Week 52 | Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively. |
Countries
France, Germany, Hungary, Japan, Poland, Russia, Spain, United States
Participant flow
Recruitment details
The study was conducted at 89 centres in 8 countries. A total of 668 participants were screened between 28 October 2014 and 04 June 2015, of which 161 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level \<7.0% or \>10% at the screening visit.
Pre-assignment details
A total of 507 participants were randomized in the study. Randomization was stratified by HbA1c at the screening visit (\<8%, \>=8%), prior use of Humalog/Liprolog (Yes, No) and geographical region (Non-Japan, Japan). Assignment to arms was done centrally using interactive voice/web response system in 1:1 ratio (SAR342434: Humalog).
Participants by arm
| Arm | Count |
|---|---|
| SAR342434 SAR342434 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. | 253 |
| Humalog Humalog 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. | 254 |
| Total | 507 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Hypoglycemia(not reported as serious AE) | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Other than specified above | 21 | 10 |
| Overall Study | Protocol Violation | 1 | 7 |
| Overall Study | Randomized but not treated | 1 | 0 |
Baseline characteristics
| Characteristic | SAR342434 | Humalog | Total |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 14.5 | 42.6 years STANDARD_DEVIATION 13.9 | 43.0 years STANDARD_DEVIATION 14.2 |
| Average Daily Basal Insulin Dose | 0.339 Units (U)/kg STANDARD_DEVIATION 0.195 | 0.33 Units (U)/kg STANDARD_DEVIATION 0.141 | 0.335 Units (U)/kg STANDARD_DEVIATION 0.17 |
| Average Daily Mealtime Insulin Dose | 0.364 U/kg STANDARD_DEVIATION 0.175 | 0.355 U/kg STANDARD_DEVIATION 0.168 | 0.360 U/kg STANDARD_DEVIATION 0.172 |
| Average Daily Total Insulin Dose | 0.704 U/kg STANDARD_DEVIATION 0.309 | 0.685 U/kg STANDARD_DEVIATION 0.242 | 0.695 U/kg STANDARD_DEVIATION 0.278 |
| Body mass index (BMI) | 26.2 kg/m^2 STANDARD_DEVIATION 4 | 25.8 kg/m^2 STANDARD_DEVIATION 4.1 | 26.0 kg/m^2 STANDARD_DEVIATION 4.1 |
| Duration of Diabetes Type 1(T1DM) | 19.53 years STANDARD_DEVIATION 12.63 | 18.57 years STANDARD_DEVIATION 11.99 | 19.05 years STANDARD_DEVIATION 12.31 |
| Glycated Haemoglobin (HbA1c %) | 8.07 percentage of hemoglobin STANDARD_DEVIATION 0.79 | 7.99 percentage of hemoglobin STANDARD_DEVIATION 0.64 | 8.03 percentage of hemoglobin STANDARD_DEVIATION 0.72 |
| Previous mealtime insulin type Both Humalog/Liprolog and NovoLog/NovoRapid | 3 Participants | 7 Participants | 10 Participants |
| Previous mealtime insulin type Humalog/Liprolog | 155 Participants | 152 Participants | 307 Participants |
| Previous mealtime insulin type NovoLog/NovoRapid | 95 Participants | 95 Participants | 190 Participants |
| Randomization strata of geographical region Japan | 31 Participants | 30 Participants | 61 Participants |
| Randomization strata of geographical region Non-Japan | 222 Participants | 224 Participants | 446 Participants |
| Randomization Strata of Screening HbA1c <8 % | 99 Participants | 99 Participants | 198 Participants |
| Randomization Strata of Screening HbA1c >=8% | 154 Participants | 155 Participants | 309 Participants |
| Sex: Female, Male Female | 104 Participants | 101 Participants | 205 Participants |
| Sex: Female, Male Male | 149 Participants | 153 Participants | 302 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 252 | 0 / 254 |
| other Total, other adverse events | 46 / 252 | 41 / 254 |
| serious Total, serious adverse events | 20 / 252 | 19 / 254 |
Outcome results
Primary
Change in HbA1c From Baseline to Week 26
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26.
Time frame: Baseline, Week 26
Population: Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, irrespective of compliance with the study protocol and procedures. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during the main 6-month period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SAR342434 | Change in HbA1c From Baseline to Week 26 | -0.42 percentage of HbA1c | Standard Error 0.051 |
| Humalog | Change in HbA1c From Baseline to Week 26 | -0.47 percentage of HbA1c | Standard Error 0.05 |
Comparison: Analysis was performed using a MMRM approach with treatment groups, randomization strata, visits and treatment-by-visit interaction as fixed categorical effects, and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.95% CI: [-0.084, 0.197]
Secondary
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26.
Time frame: Baseline, Week 26
Population: Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline FPG assessment during the main 6-month period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SAR342434 | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 | -0.46 mmol/L | Standard Error 0.248 |
| Humalog | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 | -0.62 mmol/L | Standard Error 0.248 |
Secondary
Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.
Time frame: Baseline, Week 26
Population: Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline mean 24-hour plasma glucose concentration assessment during the main 6-month period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SAR342434 | Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26 | -0.23 mmol/L | Standard Error 0.145 |
| Humalog | Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26 | -0.49 mmol/L | Standard Error 0.148 |
Secondary
Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26
Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.
Time frame: Baseline, Week 26
Population: Analysis was performed on ITT population. Here, number analyzed in each row = participants with at least one post-baseline data during the main 6-month period for specified categories.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SAR342434 | Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 | At dinner | 0.48 mmol/L | Standard Error 0.308 |
| SAR342434 | Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 | At breakfast | -0.46 mmol/L | Standard Error 0.297 |
| SAR342434 | Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 | At lunch | 0.14 mmol/L | Standard Error 0.298 |
| Humalog | Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 | At dinner | 0.56 mmol/L | Standard Error 0.324 |
| Humalog | Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 | At breakfast | 0.19 mmol/L | Standard Error 0.297 |
| Humalog | Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 | At lunch | -0.26 mmol/L | Standard Error 0.309 |
Secondary
Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year
Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. 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 symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (\<3.0 mmol/L) were also analyzed.
Time frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Population: Analysis was performed on safety population that included all participants randomized and exposed to at least 1 dose of investigational medicinal product (IMP) (SAR342434 or Humalog), regardless of the amount of treatment administered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SAR342434 | Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | Severe hypoglycemia | 0.73 events per participant-year |
| SAR342434 | Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | Documented Symptomatic Hypoglycemia (<3.0 mmol/L) | 6.29 events per participant-year |
| SAR342434 | Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | Documented Symptomatic Hypoglycemia (<=3.9 mmol/L) | 29.36 events per participant-year |
| SAR342434 | Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | Any hypoglycemia | 90.71 events per participant-year |
| Humalog | Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | Documented Symptomatic Hypoglycemia (<3.0 mmol/L) | 6.85 events per participant-year |
| Humalog | Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | Any hypoglycemia | 92.7 events per participant-year |
| Humalog | Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | Severe hypoglycemia | 0.28 events per participant-year |
| Humalog | Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year | Documented Symptomatic Hypoglycemia (<=3.9 mmol/L) | 31.37 events per participant-year |
Secondary
Percentage of Participants With HbA1c <7.0% at Week 26
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Time frame: Week 26
Population: Analysis was performed on ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SAR342434 | Percentage of Participants With HbA1c <7.0% at Week 26 | 22.5 percentage of participants |
| Humalog | Percentage of Participants With HbA1c <7.0% at Week 26 | 21.7 percentage of participants |
Secondary
Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
Percentage of participants with hypersensitivity reactions and injection site reactions were reported.
Time frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Population: Analysis was performed on safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SAR342434 | Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | Any hypersensitivity reactions | 6 percentage of participants |
| SAR342434 | Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | Any injection site reactions | 1.2 percentage of participants |
| Humalog | Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | Any hypersensitivity reactions | 6.3 percentage of participants |
| Humalog | Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | Any injection site reactions | 1.2 percentage of participants |
Secondary
Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)
Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).
Time frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Population: Analysis was performed on anti-insulin antibody population that included all participants randomized and exposed to at least 1 dose of IMP (SAR342434 or Humalog) with at least one AIA sample available for analysis during the 12-month on-treatment period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SAR342434 | Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs) | 22.6 percentage of participants |
| Humalog | Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs) | 24.2 percentage of participants |
Other Pre-specified
Change in Daily Insulin Dose From Baseline to Week 26 and Week 52
Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively.
Time frame: Baseline, Week 26, Week 52
Population: Analysis was performed on safety population. Here, number analyzed in each row = participants with available data for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAR342434 | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Basal insulin dose at Week 52 | 0.046 U/kg | Standard Deviation 0.364 |
| SAR342434 | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Total insulin dose at Week 26 | 0.019 U/kg | Standard Deviation 0.134 |
| SAR342434 | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Mealtime insulin dose at Week 26 | 0.005 U/kg | Standard Deviation 0.112 |
| SAR342434 | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Mealtime insulin dose at Week 52 | 0.018 U/kg | Standard Deviation 0.117 |
| SAR342434 | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Total insulin dose at Week 52 | 0.039 U/kg | Standard Deviation 0.135 |
| SAR342434 | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Basal insulin dose at Week 26 | 0.03 U/kg | Standard Deviation 0.236 |
| Humalog | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Total insulin dose at Week 52 | 0.019 U/kg | Standard Deviation 0.127 |
| Humalog | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Basal insulin dose at Week 26 | 0.014 U/kg | Standard Deviation 0.06 |
| Humalog | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Total insulin dose at Week 26 | 0.01 U/kg | Standard Deviation 0.111 |
| Humalog | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Basal insulin dose at Week 52 | 0.013 U/kg | Standard Deviation 0.066 |
| Humalog | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Mealtime insulin dose at Week 26 | -0.005 U/kg | Standard Deviation 0.089 |
| Humalog | Change in Daily Insulin Dose From Baseline to Week 26 and Week 52 | Mealtime insulin dose at Week 52 | 0.007 U/kg | Standard Deviation 0.104 |