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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

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ClinicalTrials.gov Identifier: NCT01658579
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : May 7, 2015
Last Update Posted : June 1, 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 (new formulation of insulin glargine)
Drug: Lantus (insulin glargine)
Enrollment 59
Recruitment Details  
Pre-assignment Details A total of 85 participants were screened, of whom 26 participants were screen failures and 59 participants were randomized. The data for outcome measures was planned to be reported for combined reporting arms (HOE901-U300 Combined and Lantus Combined).
Arm/Group Title HOE901-U300 Morning Then Evening HOE901-U300 Evening Then Morning Lantus Morning Then Evening Lantus Evening Then Morning
Hide Arm/Group Description HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L) (80-130 milligram per deciliter [mg/dL]). HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80-130 mg/dL). Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80-130 mg/dL). Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80-130 mg/dL).
Period Title: Treatment Period A
Started 15 15 15 14
Completed 14 15 14 13
Not Completed 1 0 1 1
Reason Not Completed
Other             0             0             1             1
Adverse Event             1             0             0             0
Period Title: Treatment Period B
Started 14 15 14 13
Completed 14 15 14 12
Not Completed 0 0 0 1
Reason Not Completed
Other             0             0             0             1
Arm/Group Title HOE901-U300 Morning Then Evening HOE901-U300 Evening Then Morning Lantus Morning Then Evening Lantus Evening Then Morning Total
Hide Arm/Group Description HOE901-U300 SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Lantus SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 14 59
Hide Baseline Analysis Population Description
Randomized population: all screened participants (who originally met inclusion criteria and signed informed consent) allocated to a treatment arm and recorded in Interactive Voice/Web Response System (IVRS/IWRS) database, regardless of whether treatment was used or not. Participants were analyzed in treatment arm to which they were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 14 participants 59 participants
43.6  (14.6) 46.2  (15.9) 39.7  (12.5) 47.6  (14.1) 44.2  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 14 participants 59 participants
Female
11
  73.3%
2
  13.3%
4
  26.7%
10
  71.4%
27
  45.8%
Male
4
  26.7%
13
  86.7%
11
  73.3%
4
  28.6%
32
  54.2%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 15 participants 15 participants 15 participants 14 participants 59 participants
27.5  (4.9) 27.4  (5.0) 28.3  (6.2) 26.1  (5.1) 27.3  (5.3)
Glycated Hemoglobin (HbA1c)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 14 participants 59 participants
Less Than (<) 8 11 14 12 12 49
Greater Than or Equal to (>=) 8 4 1 3 2 10
Duration of Diabetes  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 14 participants 59 participants
16.8
(3 to 48)
23.9
(2 to 54)
20.6
(5 to 47)
16.7
(6 to 44)
20.7
(2 to 54)
Basal Insulin Daily Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Units per kilogram (U/kg)
Number Analyzed 15 participants 15 participants 15 participants 14 participants 59 participants
0.309  (0.086) 0.283  (0.088) 0.341  (0.100) 0.267  (0.055) 0.301  (0.087)
[1]
Measure Description: Number of participants analyzed for this baseline characteristics =15, 14, 15, and 13 for each reporting group, respectively.
Total Insulin Daily Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  U/kg
Number Analyzed 15 participants 15 participants 15 participants 14 participants 59 participants
0.600  (0.237) 0.620  (0.179) 0.677  (0.204) 0.513  (0.115) 0.603  (0.193)
[1]
Measure Description: Number of participants analyzed for this baseline characteristics = 13, 13, 13, 13 for each reporting group, respectively.
1.Primary Outcome
Title Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
Hide Description Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.
Time Frame Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
Continuous glucose monitoring (CGM) population: All participants who received at least 1 dose, had evaluable post-baseline CGM data, irrespective of compliance. Number of participants analyzed = participants with baseline, Weeks 7-8 (Period A) and/or Weeks 15-16 (Period B) CGM assessment. Missing data imputed using last observation carried forward.
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 30 27
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time
31.75  (1.5) 30.99  (1.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HOE901-U300 Combined, Lantus Combined
Comments Analysis was performed using a linear mixed model with treatment and period as fixed effects, and participant as random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7304
Comments [Not Specified]
Method Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
-3.614 to 5.124
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.179
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])
Hide Description Percentage of time with glucose above the upper limit of glycemic range (>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval.
Time Frame Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using last observation carried forward (LOCF).
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 30 27
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time
58.24  (2.09) 57.38  (2.2)
3.Secondary Outcome
Title Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])
Hide Description Percentage of time with glucose below the lower limit of glycemic range (<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval.
Time Frame Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 30 27
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time
10.01  (1.02) 11.64  (1.08)
4.Secondary Outcome
Title Evaluation of Diurnal Glucose Exposure, Variability, and Stability
Hide Description The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval.
Time Frame Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 30 27
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
Diurnal Glucose Exposure 8.869  (0.24) 8.910  (0.26)
Diurnal Glucose Stability 0.673  (0.03) 0.703  (0.03)
Diurnal Glucose Variability 4.931  (0.22) 5.279  (0.23)
5.Secondary Outcome
Title Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B
Hide Description Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.
Time Frame Weeks 7-8 in Period A and Weeks 15-16 in Period B
Hide Outcome Measure Data
Hide Analysis Population Description
CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment, and n = participants with assessment at specified time-point.
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 29 27
Mean (Standard Deviation)
Unit of Measure: percentage of time
Week 7, 8 (n=28, 27) 32.08  (14.74) 29.07  (13.82)
Week 15, 16 (n=29, 26) 33.02  (13.48) 28.70  (14.57)
6.Secondary Outcome
Title Change in HbA1c From Baseline to Week 8 and 16
Hide Description [Not Specified]
Time Frame Baseline, Week 8, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat population: randomized participants who received at least 1 dose; had baseline, at least 1 post-baseline efficacy assessment; irrespective of compliance. Number of participants analyzed = participants with baseline, Week 8 and/or 16 HbA1c assessment, n = participants with HbA1c assessment at specified time. LOCF applied.
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 29 27
Mean (Standard Deviation)
Unit of Measure: percentage of hemoglobin
Week 8 (n= 29, 20) -0.22  (0.48) -0.23  (0.54)
Week 16 (n= 28, 27) -0.44  (0.51) -0.22  (0.58)
7.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16
Hide Description [Not Specified]
Time Frame Baseline, Week 8, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 FPG assessment, n = participants with FPG assessment at specified time. Missing data imputed using LOCF.
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 24 23
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 8 (n=24, 23) -0.89  (5.04) -0.10  (5.81)
Week 16 (n= 24, 22) -0.99  (5.27) 0.78  (4.92)
8.Secondary Outcome
Title Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16
Hide Description Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime.
Time Frame Baseline, Week 8, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 7-point SMPG assessment, n = participants with 7-point SMPG assessment at specified time. Missing data imputed using LOCF.
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 8 -0.39  (1.84) 0.39  (1.54)
Week 16 -0.47  (1.31) 0.58  (2.13)
9.Secondary Outcome
Title Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16
Hide Description [Not Specified]
Time Frame Baseline, Week 8, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat population. Here n = participants with basal insulin dose assessment at specified time-point. Missing data imputed using LOCF.
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: U/kg
Week 8 (n= 30, 29) 0.06  (0.09) 0.03  (0.09)
Week 16 (n=29, 27) 0.05  (0.09) 0.03  (0.08)
10.Secondary Outcome
Title Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16
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 Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all randomized participants who were exposed to at least one dose, regardless of 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 Combined Lantus Combined
Hide Arm/Group Description:
HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
Overall Number of Participants Analyzed 30 29
Measure Type: Number
Unit of Measure: percentage of participants
Any Hypoglycemia Event: All Hypoglycemia 100 100
Severe Hypoglycemia: All Hypoglycemia 3.3 10.3
Documented Symptomatic: All Hypoglycemia 93.3 96.6
Asymptomatic: All Hypoglycemia 86.7 96.6
Probable Symptomatic: All Hypoglycemia 16.7 27.6
Relative: All Hypoglycemia 0.0 6.9
Severe and/or Confirmed: All Hypoglycemia 100 100
Any Hypoglycemia Event: Nocturnal Hypoglycemia 80.0 93.1
Severe Hypoglycemia: Nocturnal Hypoglycemia 0.0 6.9
Documented Symptomatic: Nocturnal Hypoglycemia 66.7 79.3
Asymptomatic: Nocturnal Hypoglycemia 40.0 48.3
Probable Symptomatic: Nocturnal Hypoglycemia 3.3 10.3
Relative: Nocturnal Hypoglycemia 0.0 6.9
Severe and/or Confirmed: Nocturnal Hypoglycemia 80.0 93.1
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (the time from first dose of study drug up to 2 days after the last dose of study drug). Analysis was done on safety population.
 
Arm/Group Title HOE901-U300 Combined Lantus Combined
Hide Arm/Group Description HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B. Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
All-Cause Mortality
HOE901-U300 Combined Lantus Combined
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
HOE901-U300 Combined Lantus Combined
Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   0/29 (0.00%) 
Gastrointestinal disorders     
Intestinal obstruction  1  1/30 (3.33%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HOE901-U300 Combined Lantus Combined
Affected / at Risk (%) Affected / at Risk (%)
Total   18/30 (60.00%)   17/29 (58.62%) 
Gastrointestinal disorders     
Diarrhoea  1  3/30 (10.00%)  1/29 (3.45%) 
Nausea  1  2/30 (6.67%)  1/29 (3.45%) 
Vomiting  1  0/30 (0.00%)  3/29 (10.34%) 
General disorders     
Implant site bruising  1  3/30 (10.00%)  0/29 (0.00%) 
Pyrexia  1  3/30 (10.00%)  2/29 (6.90%) 
Fatigue  1  2/30 (6.67%)  2/29 (6.90%) 
Infections and infestations     
Nasopharyngitis  1  9/30 (30.00%)  6/29 (20.69%) 
Influenza  1  2/30 (6.67%)  3/29 (10.34%) 
Investigations     
Weight increased  1  2/30 (6.67%)  0/29 (0.00%) 
Nervous system disorders     
Headache  1  2/30 (6.67%)  4/29 (13.79%) 
Migraine  1  2/30 (6.67%)  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders     
Sinus congestion  1  2/30 (6.67%)  1/29 (3.45%) 
Cough  1  1/30 (3.33%)  2/29 (6.90%) 
Nasal congestion  1  1/30 (3.33%)  2/29 (6.90%) 
Oropharyngeal pain  1  1/30 (3.33%)  2/29 (6.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: NCT01658579    
Other Study ID Numbers: PDY12777
U1111-1130-3593 ( Other Identifier: UTN )
First Submitted: July 26, 2012
First Posted: August 7, 2012
Results First Submitted: March 24, 2015
Results First Posted: May 7, 2015
Last Update Posted: June 1, 2015