Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus (EDITION IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01683266
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : April 23, 2015
Last Update Posted : June 24, 2015
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 1 Diabetes Mellitus
Interventions Drug: HOE901-U300 (Insulin glargine new formulation)
Drug: Lantus (Insulin glargine)
Enrollment 549
Recruitment Details A total of 846 participants were screened, of whom 297 participants were screen failure and 549 participants were randomized.
Pre-assignment Details  
Arm/Group Title HOE901­-U300 Lantus
Hide Arm/Group Description HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
Period Title: Overall Study
Started 274 275
Modified Intent-to-Treat Population 273 [1] 273 [1]
Completed 219 225
Not Completed 55 50
Reason Not Completed
Adverse Event             5             4
Lack of Efficacy             5             2
Protocol Violation             13             6
Personal Reason             17             25
Selection Criterion / Protocol Violation             7             5
Lost to Follow-up             5             0
Site Closure / Site Withdrawal             1             3
Nonserious Hypoglycemia             0             3
Perceived Lack of Efficacy             1             1
Possibly Hypoglycemia             1             0
Serious Adverse Event of Hypoglycemia             0             1
[1]
Participants who received at least 1 dose of drug, had both baseline, at least 1 post-baseline data
Arm/Group Title HOE901­-U300 Lantus Total
Hide Arm/Group Description HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin. Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin. Total of all reporting groups
Overall Number of Baseline Participants 274 275 549
Hide Baseline Analysis Population Description
Randomized population: all screened participants (who originally met inclusion criteria and signed informed consent) allocated to a treatment group and recorded in Interactive Voice/Web Response System (IVRS/IWRS) database, regardless of whether treatment was used or not. Participants were analyzed in treatment group to which they were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants 275 participants 549 participants
46.4  (13.9) 48.2  (13.4) 47.3  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 275 participants 549 participants
Female
125
  45.6%
111
  40.4%
236
  43.0%
Male
149
  54.4%
164
  59.6%
313
  57.0%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 274 participants 275 participants 549 participants
27.6  (5.5) 27.6  (4.7) 27.6  (5.1)
Duration of Diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants 275 participants 549 participants
20.5  (12.7) 21.4  (13.1) 21.0  (12.9)
[1]
Measure Description: Number of participants analyzed for this baseline characteristics = 274 and 272 for each reporting group, respectively.
Glycated Hemoglobin (HbA1c)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 274 participants 275 participants 549 participants
Less Than (<) 8% 105 105 210
Greater Than or Equal to (>=) 8% 169 170 339
Basal Insulin Daily Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Units per kilogram (U/kg)
Number Analyzed 274 participants 275 participants 549 participants
0.381  (0.173) 0.372  (0.152) 0.376  (0.162)
[1]
Measure Description: Number of participants analyzed for this baseline characteristics = 201 and 210 for each reporting group, respectively.
Total Insulin Daily Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  U/kg
Number Analyzed 274 participants 275 participants 549 participants
0.714  (0.278) 0.724  (0.245) 0.719  (0.262)
[1]
Measure Description: Number of participants analyzed for this baseline characteristics = 195 and 198 for each reporting group, respectively.
1.Primary Outcome
Title Change In HbA1c From Baseline to Month 6 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post­baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment.
Arm/Group Title HOE901­-U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 225 229
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-0.40  (0.051) -0.44  (0.051)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HOE901­-U300, Lantus
Comments 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.
Type of Statistical Test Non-Inferiority or Equivalence
Comments

Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:

  1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is <0.4%.
  2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is <0.
Method of Estimation Estimation Parameter Least Squares (LS) Mean difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.098 to 0.185
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.072
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population.
Arm/Group Title HOE901­-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 273 273
Measure Type: Number
Unit of Measure: percentage of participants
16.8 15.0
3.Secondary Outcome
Title Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population.
Arm/Group Title HOE901-­U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 273 273
Measure Type: Number
Unit of Measure: percentage of participants
8.1 5.5
4.Secondary Outcome
Title Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint
Hide Description Pre­injection 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.
Arm/Group Title HOE901­-U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 117 105
Least Squares Mean (Standard Error)
Unit of Measure: millimole per liter (mmol/L)
-1.16  (0.223) -0.82  (0.233)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HOE901­-U300, Lantus
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.982 to 0.287
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.322
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint
Hide Description Pre­injection 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.
Arm/Group Title HOE901­-U300 Lantus
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 117 105
Least Squares Mean (Standard Error)
Unit of Measure: percentage of mean
-3.03  (1.573) -1.76  (1.651)
6.Secondary Outcome
Title Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.
Arm/Group Title HOE901-­U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 213 216
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.95  (0.263) -1.14  (0.260)
7.Secondary Outcome
Title Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population.
Arm/Group Title HOE901-­U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 273 273
Measure Type: Number
Unit of Measure: percentage of participants
9.9 12.8
8.Secondary Outcome
Title Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.
Arm/Group Title HOE901-­U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 273 273
Measure Type: Number
Unit of Measure: percentage of participants
25.3 25.6
9.Secondary Outcome
Title Change in 8-­Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
Hide Description Change in each time­point 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Here, n = participants with Baseline and Month 6 8­point SMPG assessment separately for each analysed time point.
Arm/Group Title HOE901­-U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 273 273
Mean (Standard Deviation)
Unit of Measure: mmol/L
03:00 at Night (n= 156, 159) -0.47  (4.56) -0.67  (4.98)
Pre­-Breakfast (n= 166, 167) -0.86  (5.30) -0.07  (5.20)
2 Hours After Breakfast (n= 152, 156) -0.62  (4.75) -1.18  (5.66)
Pre-­Lunch (n= 166, 166) -0.95  (4.53) -0.93  (4.76)
2 Hours After Lunch (n= 163,163) -0.13  (5.20) -1.43  (5.37)
Pre­-Dinner (n= 165,166) -0.56  (6.00) -1.74  (5.28)
2 Hours After Dinner (n= 154,152) -0.93  (5.27) -1.19  (5.51)
Bedtime (n= 141,146) -0.80  (5.39) -1.91  (5.10)
10.Secondary Outcome
Title Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint
Hide Description [Not Specified]
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.
Arm/Group Title HOE901­-U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 173 158
Mean (Standard Deviation)
Unit of Measure: U/kg
0.19  (0.22) 0.10  (0.16)
11.Secondary Outcome
Title Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
Hide Description 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 4­8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.
Arm/Group Title HOE901-­U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 212 206
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.00  (0.331) 1.41  (0.334)
12.Secondary Outcome
Title Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title HOE901-­U300 Lantus
Hide Arm/Group Description:
HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Overall Number of Participants Analyzed 274 275
Measure Type: Number
Unit of Measure: percentage of participants
Any Hypoglycemia Event: All Hypoglycemia 95.3 94.9
Severe Hypoglycemia: All Hypoglycemia 9.1 11.3
Documented Symptomatic: All Hypoglycemia 87.6 86.5
Asymptomatic: All Hypoglycemia 76.6 81.5
Probable Symptomatic: All Hypoglycemia 11.3 15.3
Relative: All Hypoglycemia 14.6 9.5
Severe and/or Confirmed: All Hypoglycemia 94.9 94.5
Any Hypoglycemia Event: Nocturnal Hypoglycemia 73.4 74.9
Severe Hypoglycemia: Nocturnal Hypoglycemia 3.3 3.3
Documented Symptomatic: Nocturnal Hypoglycemia 64.2 63.3
Asymptomatic: Nocturnal Hypoglycemia 35.0 38.9
Probable Symptomatic: Nocturnal Hypoglycemia 5.1 6.5
Relative: Nocturnal Hypoglycemia 4.0 5.5
Severe and/or Confirmed: Nocturnal Hypoglycemia 72.6 74.5
Time Frame All Adverse Events (AE) were collected from signature of informed consent form up to study completion regardless of seriousness or relationship to study drug.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (as the time from first injection of IMP up to 2 days after the last injection of IMP). Analysis was done on safety population.
 
Arm/Group Title HOE901-­U300 Lantus
Hide Arm/Group Description HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin. Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
All-Cause Mortality
HOE901-­U300 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HOE901-­U300 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   27/274 (9.85%)   26/275 (9.45%) 
Cardiac disorders     
Angina pectoris  1  0/274 (0.00%)  1/275 (0.36%) 
Atrioventricular block complete  1  1/274 (0.36%)  0/275 (0.00%) 
Coronary artery disease  1  1/274 (0.36%)  0/275 (0.00%) 
Gastrointestinal disorders     
Ileus  1  0/274 (0.00%)  1/275 (0.36%) 
General disorders     
Non-cardiac chest pain  1  0/274 (0.00%)  1/275 (0.36%) 
Immune system disorders     
Hypersensitivity  1  1/274 (0.36%)  0/275 (0.00%) 
Infections and infestations     
Appendicitis  1  0/274 (0.00%)  1/275 (0.36%) 
Cellulitis  1  1/274 (0.36%)  0/275 (0.00%) 
Chronic tonsillitis  1  0/274 (0.00%)  1/275 (0.36%) 
Erysipelas  1  1/274 (0.36%)  0/275 (0.00%) 
H1N1 influenza  1  1/274 (0.36%)  0/275 (0.00%) 
Pyelonephritis  1  1/274 (0.36%)  0/275 (0.00%) 
Urinary tract infection  1  0/274 (0.00%)  1/275 (0.36%) 
Viral infection  1  1/274 (0.36%)  0/275 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/274 (0.36%)  0/275 (0.00%) 
Brain contusion  1  0/274 (0.00%)  1/275 (0.36%) 
Comminuted fracture  1  1/274 (0.36%)  0/275 (0.00%) 
Fall  1  0/274 (0.00%)  1/275 (0.36%) 
Joint dislocation  1  0/274 (0.00%)  1/275 (0.36%) 
Open fracture  1  1/274 (0.36%)  0/275 (0.00%) 
Overdose  1  1/274 (0.36%)  0/275 (0.00%) 
Patella fracture  1  1/274 (0.36%)  0/275 (0.00%) 
Pelvic fracture  1  0/274 (0.00%)  1/275 (0.36%) 
Rib fracture  1  0/274 (0.00%)  1/275 (0.36%) 
Road traffic accident  1  1/274 (0.36%)  2/275 (0.73%) 
Spinal compression fracture  1  1/274 (0.36%)  0/275 (0.00%) 
Subdural haematoma  1  0/274 (0.00%)  1/275 (0.36%) 
Tendon rupture  1  1/274 (0.36%)  0/275 (0.00%) 
Thoracic vertebral fracture  1  0/274 (0.00%)  1/275 (0.36%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  2/274 (0.73%)  1/275 (0.36%) 
Hypoglycaemia  1  16/274 (5.84%)  13/275 (4.73%) 
Musculoskeletal and connective tissue disorders     
Dupuytren's contracture  1  0/274 (0.00%)  1/275 (0.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma  1  0/274 (0.00%)  1/275 (0.36%) 
Nervous system disorders     
Aphasia  1  0/274 (0.00%)  1/275 (0.36%) 
Convulsion  1  1/274 (0.36%)  0/275 (0.00%) 
Diabetic neuropathy  1  0/274 (0.00%)  1/275 (0.36%) 
Hypoglycaemic seizure  1  1/274 (0.36%)  1/275 (0.36%) 
Hypoglycaemic unconsciousness  1  1/274 (0.36%)  1/275 (0.36%) 
Loss of consciousness  1  1/274 (0.36%)  1/275 (0.36%) 
Syncope  1  0/274 (0.00%)  1/275 (0.36%) 
Renal and urinary disorders     
Renal failure acute  1  0/274 (0.00%)  1/275 (0.36%) 
Urinary retention  1  0/274 (0.00%)  1/275 (0.36%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  0/274 (0.00%)  1/275 (0.36%) 
Urticaria  1  1/274 (0.36%)  0/275 (0.00%) 
Vascular disorders     
Femoral artery occlusion  1  1/274 (0.36%)  0/275 (0.00%) 
Hypertension  1  0/274 (0.00%)  1/275 (0.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 17.0
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   113/274 (41.24%)   86/275 (31.27%) 
Infections and infestations     
Influenza  1  16/274 (5.84%)  14/275 (5.09%) 
Nasopharyngitis  1  43/274 (15.69%)  35/275 (12.73%) 
Sinusitis  1  14/274 (5.11%)  11/275 (4.00%) 
Upper respiratory tract infection  1  38/274 (13.87%)  26/275 (9.45%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  14/274 (5.11%)  7/275 (2.55%) 
Nervous system disorders     
Headache  1  17/274 (6.20%)  13/275 (4.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 17.0
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: NCT01683266     History of Changes
Other Study ID Numbers: EFC12456
2012-001524-35 ( EudraCT Number )
U1111-1128-5517 ( Other Identifier: UTN )
First Submitted: September 7, 2012
First Posted: September 11, 2012
Results First Submitted: March 24, 2015
Results First Posted: April 23, 2015
Last Update Posted: June 24, 2015