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Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications (SENIOR)

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ClinicalTrials.gov Identifier: NCT02320721
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Insulin Glargine (HOE901 - U300)
Drug: Insulin Glargine (HOE901 - U100)
Drug: Background therapy
Enrollment 1014
Recruitment Details The study was conducted at 162 study centers across 18 countries. A total of 1515 participants were screened between 16 January 2015 and 14 October 2015, of whom 501 were screen failures.
Pre-assignment Details A total of 1014 participants were randomized in 1:1 ratio to either HOE901-U300 or Lantus, stratified by screening hemoglobin A1c (HbA1c) values (<8% or ≥8%); previous use of insulin (insulin-naïve versus pre-treated); and use of sulfonylurea or meglitinides at screening (’yes’ versus ‘no’).
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Period Title: Overall Study
Started 508 506
Treated (Safety Population) 508 505
Completed 481 472
Not Completed 27 34
Reason Not Completed
Adverse Event             6             6
Lack of Efficacy             2             0
Poor compliance to protocol             3             7
Randomized but not treated             0             1
Hypoglycemia             1             0
Other than specified above             15             20
Arm/Group Title HOE901-U300 Lantus Total
Hide Arm/Group Description HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. Total of all reporting groups
Overall Number of Baseline Participants 508 506 1014
Hide Baseline Analysis Population Description
Baseline population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 508 participants 506 participants 1014 participants
71.1  (4.9) 70.8  (4.8) 71.0  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 508 participants 506 participants 1014 participants
Female
258
  50.8%
229
  45.3%
487
  48.0%
Male
250
  49.2%
277
  54.7%
527
  52.0%
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 508 participants 505 participants 1013 participants
30.9  (5.5) 31.2  (5.7) 31.1  (5.6)
[1]
Measure Analysis Population Description: Number of participants analyzed = participants with available data for this baseline measure.
Duration of Type 2 Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 508 participants 506 participants 1014 participants
15.29  (8.17) 15.35  (7.70) 15.32  (7.93)
Baseline Glycated Hemoglobin A1c (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of HbA1c
Number Analyzed 508 participants 506 participants 1014 participants
8.20  (0.91) 8.22  (0.92) 8.21  (0.91)
Randomization strata of insulin  
Measure Type: Count of Participants
Unit of measure:  Participants
Insulin-naive Number Analyzed 508 participants 506 participants 1014 participants
166
  32.7%
165
  32.6%
331
  32.6%
Insulin pre-treated Number Analyzed 508 participants 506 participants 1014 participants
342
  67.3%
341
  67.4%
683
  67.4%
Age Group  
Measure Type: Count of Participants
Unit of measure:  Participants
<75 years of age Number Analyzed 508 participants 506 participants 1014 participants
373
  73.4%
400
  79.1%
773
  76.2%
≥75 years of age Number Analyzed 508 participants 506 participants 1014 participants
135
  26.6%
106
  20.9%
241
  23.8%
1.Primary Outcome
Title Change in HbA1c From Baseline to Week 26
Hide Description Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants regardless of whether the treatment kit was used, and analyzed according to the treatment group allocated by randomization.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 506
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-0.89  (0.038) -0.91  (0.042)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HOE901-U300, Lantus
Comments Analysis was performed using ANCOVA model including the fixed categorical effects of treatment group, randomization strata, as well as the continuous fixed covariates of baseline value and following multiple imputation procedure for missing data.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of HOE901-U300 vs Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was <0.3%.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.092 to 0.129
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.056
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period
Hide Description Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL).
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 506
Measure Type: Number
Unit of Measure: percentage of participants
48.3 47.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HOE901-U300, Lantus
Comments Analysis was done by Cochran-Mantel-Haenszel method with randomization strata (screening HbA1c [<8.0%; ≥8.0%], previous use of insulin [naive, pre-treated], use of sulfonylurea or meglitinides at screening [yes, no]), following multiple imputation procedure for missing data.
Type of Statistical Test Superiority or Other
Comments A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only if previous endpoint was statistically significant at 0.05 level.
Statistical Test of Hypothesis P-Value 0.8415
Comments Threshold for significance at 0.05 level.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative risk
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.890 to 1.153
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period
Hide Description Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL).
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 506
Measure Type: Number
Unit of Measure: percentage of participants
20.2 22.5
4.Secondary Outcome
Title Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period
Hide Description Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL).
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 506
Measure Type: Number
Unit of Measure: percentage of participants
59.4 62.7
5.Secondary Outcome
Title Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period
Hide Description Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 506
Measure Type: Number
Unit of Measure: percentage of participants
HbA1c <7.5% 60.6 58.9
HbA1c <7.0% 33.3 35.2
6.Secondary Outcome
Title Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period
Hide Description 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 ≤3.9 mmol/L (70 mg/dL).
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 506
Measure Type: Number
Unit of Measure: percentage of participants
HbA1c <7.5% 26.4 21.5
HbA1c <7.0% 14.0 12.3
7.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Hide Description Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here 'Overall number of participants analyzed' signifies participants with available data for this outcome measure.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 484 482
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.68  (0.122) -1.77  (0.135)
8.Secondary Outcome
Title Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26
Hide Description WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here ‘Overall number of participants analyzed’ signifies participants with available data for this outcome measure.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 484 476
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.16  (0.751) 0.22  (0.758)
9.Secondary Outcome
Title Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment
Hide Description Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%.
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 506
Measure Type: Number
Unit of Measure: percentage of participants
3.7 2.6
10.Other Pre-specified Outcome
Title Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment
Hide Description Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who actually received at least 1 dose or part of a dose of investigational medicinal product (IMP) and analyzed according to the treatment actually received.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 505
Measure Type: Number
Unit of Measure: percentage of participants
Any hypoglycemia Number Analyzed 508 participants 505 participants
62.6 66.5
Documented symptomatic hypoglycemia Number Analyzed 508 participants 505 participants
32.9 34.7
Severe and/or confirmed hypoglycemia Number Analyzed 508 participants 505 participants
58.1 60.6
Severe and/or confirmed hypoglycemia:<75 years age Number Analyzed 373 participants 399 participants
59.2 60.9
Severe and/or confirmed hypoglycemia:≥75 years age Number Analyzed 135 participants 106 participants
54.8 59.4
11.Other Pre-specified Outcome
Title Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment
Hide Description Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 505
Measure Type: Number
Unit of Measure: events per participant year
Any hypoglycemia 6.06 7.74
Documented symptomatic hypoglycemia 1.85 2.56
Severe and/or confirmed hypoglycemia 5.17 6.36
12.Post-Hoc Outcome
Title Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment
Hide Description Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Time Frame Baseline up to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Overall Number of Participants Analyzed 508 505
Measure Type: Number
Unit of Measure: events per participant year
Any hypoglycemia:<75 years age Number Analyzed 373 participants 399 participants
6.44 7.85
Any hypoglycemia:≥75 years age Number Analyzed 135 participants 106 participants
5.01 7.32
Documented symptomatic hypoglycemia:<75 years age Number Analyzed 373 participants 399 participants
2.11 2.52
Documented symptomatic hypoglycemia:≥75 years age Number Analyzed 135 participants 106 participants
1.12 2.71
Severe and/or confirmed hypoglycemia:<75 years age Number Analyzed 373 participants 399 participants
5.43 6.37
Severe and/or confirmed hypoglycemia:≥75 years age Number Analyzed 135 participants 106 participants
4.46 6.28
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Adverse Event Reporting Description Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
 
Arm/Group Title HOE901-U300 Lantus
Hide Arm/Group Description HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
All-Cause Mortality
HOE901-U300 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   1/508 (0.20%)   0/505 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
HOE901-U300 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   41/508 (8.07%)   34/505 (6.73%) 
Blood and lymphatic system disorders     
Anaemia  1  0/508 (0.00%)  1/505 (0.20%) 
Cardiac disorders     
Acute left ventricular failure  1  0/508 (0.00%)  1/505 (0.20%) 
Acute myocardial infarction  1  2/508 (0.39%)  1/505 (0.20%) 
Angina unstable  1  2/508 (0.39%)  0/505 (0.00%) 
Atrial fibrillation  1  0/508 (0.00%)  2/505 (0.40%) 
Atrioventricular block  1  1/508 (0.20%)  0/505 (0.00%) 
Cardiac failure chronic  1  0/508 (0.00%)  1/505 (0.20%) 
Cardiac failure congestive  1  1/508 (0.20%)  0/505 (0.00%) 
Coronary artery disease  1  2/508 (0.39%)  2/505 (0.40%) 
Myocardial ischaemia  1  0/508 (0.00%)  1/505 (0.20%) 
Sinus node dysfunction  1  1/508 (0.20%)  0/505 (0.00%) 
Tachycardia  1  1/508 (0.20%)  0/505 (0.00%) 
Endocrine disorders     
Adrenal mass  1  1/508 (0.20%)  0/505 (0.00%) 
Gastrointestinal disorders     
Gastric ulcer haemorrhage  1  1/508 (0.20%)  0/505 (0.00%) 
Ileus  1  0/508 (0.00%)  1/505 (0.20%) 
Rectal haemorrhage  1  1/508 (0.20%)  0/505 (0.00%) 
General disorders     
Death  1  1/508 (0.20%)  0/505 (0.00%) 
Hepatobiliary disorders     
Bile duct stone  1  1/508 (0.20%)  0/505 (0.00%) 
Cholecystitis  1  1/508 (0.20%)  0/505 (0.00%) 
Cholecystitis acute  1  1/508 (0.20%)  0/505 (0.00%) 
Infections and infestations     
Arthritis infective  1  1/508 (0.20%)  0/505 (0.00%) 
Bacterial pyelonephritis  1  0/508 (0.00%)  1/505 (0.20%) 
Diverticulitis  1  0/508 (0.00%)  1/505 (0.20%) 
Empyema  1  0/508 (0.00%)  1/505 (0.20%) 
Endocarditis bacterial  1  1/508 (0.20%)  0/505 (0.00%) 
Lung infection  1  0/508 (0.00%)  1/505 (0.20%) 
Osteomyelitis  1  1/508 (0.20%)  0/505 (0.00%) 
Perirectal abscess  1  1/508 (0.20%)  0/505 (0.00%) 
Pneumonia  1  1/508 (0.20%)  3/505 (0.59%) 
Pyelonephritis  1  0/508 (0.00%)  2/505 (0.40%) 
Urosepsis  1  1/508 (0.20%)  0/505 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/508 (0.00%)  1/505 (0.20%) 
Fall  1  1/508 (0.20%)  0/505 (0.00%) 
Femur fracture  1  0/508 (0.00%)  1/505 (0.20%) 
Heart injury  1  0/508 (0.00%)  1/505 (0.20%) 
Investigations     
Hepatic enzyme increased  1  1/508 (0.20%)  0/505 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  1/508 (0.20%)  0/505 (0.00%) 
Hypoglycaemia  1  1/508 (0.20%)  1/505 (0.20%) 
Hyponatraemia  1  1/508 (0.20%)  0/505 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/508 (0.20%)  0/505 (0.00%) 
Chondrocalcinosis pyrophosphate  1  1/508 (0.20%)  0/505 (0.00%) 
Osteoarthritis  1  0/508 (0.00%)  1/505 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/508 (0.20%)  0/505 (0.00%) 
Basal cell carcinoma  1  1/508 (0.20%)  1/505 (0.20%) 
Bladder cancer  1  0/508 (0.00%)  1/505 (0.20%) 
Bowen's disease  1  1/508 (0.20%)  0/505 (0.00%) 
Breast cancer  1  0/508 (0.00%)  1/505 (0.20%) 
Chronic lymphocytic leukaemia  1  1/508 (0.20%)  0/505 (0.00%) 
Endometrial cancer metastatic  1  1/508 (0.20%)  0/505 (0.00%) 
Glioblastoma  1  0/508 (0.00%)  1/505 (0.20%) 
Hepatic neoplasm  1  0/508 (0.00%)  1/505 (0.20%) 
Lung adenocarcinoma  1  1/508 (0.20%)  0/505 (0.00%) 
Lung neoplasm  1  0/508 (0.00%)  1/505 (0.20%) 
Oesophageal adenocarcinoma  1  0/508 (0.00%)  1/505 (0.20%) 
Pancreatic carcinoma  1  2/508 (0.39%)  0/505 (0.00%) 
Prostate cancer  1  3/508 (0.59%)  1/505 (0.20%) 
Rectal cancer  1  0/508 (0.00%)  1/505 (0.20%) 
Squamous cell carcinoma of skin  1  1/508 (0.20%)  0/505 (0.00%) 
Transitional cell carcinoma  1  0/508 (0.00%)  1/505 (0.20%) 
Nervous system disorders     
Embolic stroke  1  1/508 (0.20%)  0/505 (0.00%) 
Hypoglycaemic coma  1  1/508 (0.20%)  0/505 (0.00%) 
Hypoglycaemic unconsciousness  1  1/508 (0.20%)  0/505 (0.00%) 
IIIrd nerve paresis  1  1/508 (0.20%)  0/505 (0.00%) 
Ischaemic stroke  1  2/508 (0.39%)  0/505 (0.00%) 
Loss of consciousness  1  1/508 (0.20%)  0/505 (0.00%) 
Neuromyopathy  1  1/508 (0.20%)  0/505 (0.00%) 
Syncope  1  1/508 (0.20%)  1/505 (0.20%) 
Transient ischaemic attack  1  0/508 (0.00%)  1/505 (0.20%) 
Renal and urinary disorders     
Acute kidney injury  1  1/508 (0.20%)  1/505 (0.20%) 
Chronic kidney disease  1  1/508 (0.20%)  0/505 (0.00%) 
Renal colic  1  0/508 (0.00%)  1/505 (0.20%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/508 (0.20%)  0/505 (0.00%) 
Breast mass  1  0/508 (0.00%)  1/505 (0.20%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  1/508 (0.20%)  0/505 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/508 (0.20%)  0/505 (0.00%) 
Vascular disorders     
Hypertensive crisis  1  1/508 (0.20%)  2/505 (0.40%) 
Peripheral venous disease  1  1/508 (0.20%)  0/505 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HOE901-U300 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   62/508 (12.20%)   64/505 (12.67%) 
Infections and infestations     
Nasopharyngitis  1  37/508 (7.28%)  38/505 (7.52%) 
Upper respiratory tract infection  1  27/508 (5.31%)  28/505 (5.54%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02320721     History of Changes
Other Study ID Numbers: EFC13799
2014-002399-10
U1111-1159-3018 ( Other Identifier: UTN )
First Submitted: December 16, 2014
First Posted: December 19, 2014
Results First Submitted: May 18, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017