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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01683266
First received: September 7, 2012
Last updated: April 22, 2015
Last verified: April 2015
Results First Received: March 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: HOE901-U300 (Insulin glargine new formulation)
Drug: Lantus (Insulin glargine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 846 participants were screened, of whom 297 participants were screen failure and 549 participants were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HOE901­-U300 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 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.

Participant Flow:   Overall Study
    HOE901­-U300     Lantus  
STARTED     274     275  
Modified Intent-to-Treat Population     273 [1]   273 [1]
COMPLETED     219     225  
NOT COMPLETED     55     50  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
HOE901­-U300 HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Lantus Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
Total Total of all reporting groups

Baseline Measures
    HOE901­-U300     Lantus     Total  
Number of Participants  
[units: participants]
  274     275     549  
Age  
[units: years]
Mean ± Standard Deviation
  46.4  ± 13.9     48.2  ± 13.4     47.3  ± 13.7  
Gender  
[units: participants]
     
Female     125     111     236  
Male     149     164     313  
Body Mass Index (BMI)  
[units: kilogram per square meter (kg/m^2)]
Mean ± Standard Deviation
  27.6  ± 5.5     27.6  ± 4.7     27.6  ± 5.1  
Duration of Diabetes [1]
[units: years]
Mean ± Standard Deviation
  20.5  ± 12.7     21.4  ± 13.1     21.0  ± 12.9  
Glycated Hemoglobin (HbA1c)  
[units: participants]
     
Less Than (<) 8%     105     105     210  
Greater Than or Equal to (>=) 8%     169     170     339  
Basal Insulin Daily Dose [2]
[units: units per kilogram (U/kg)]
Mean ± Standard Deviation
  0.381  ± 0.173     0.372  ± 0.152     0.376  ± 0.162  
Total Insulin Daily Dose [3]
[units: U/kg]
Mean ± Standard Deviation
  0.714  ± 0.278     0.724  ± 0.245     0.719  ± 0.262  
[1] Number of participants analyzed for this baseline characteristics = 274 and 272 for each reporting group, respectively.
[2] Number of participants analyzed for this baseline characteristics = 201 and 210 for each reporting group, respectively.
[3] Number of participants analyzed for this baseline characteristics = 195 and 198 for each reporting group, respectively.



  Outcome Measures
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1.  Primary:   Change In HbA1c From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

2.  Secondary:   Percentage of Participants With HbA1c <7% at Month 6 Endpoint   [ Time Frame: Month 6 ]

3.  Secondary:   Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint   [ Time Frame: Month 6 ]

4.  Secondary:   Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

5.  Secondary:   Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

6.  Secondary:   Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

7.  Secondary:   Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6   [ Time Frame: Month 6 ]

8.  Secondary:   Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint   [ Time Frame: Month 6 ]

9.  Secondary:   Change in 8-­Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

10.  Secondary:   Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

11.  Secondary:   Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

12.  Secondary:   Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12   [ Time Frame: Up to Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact­-US@sanofi.com


No publications provided


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01683266     History of Changes
Other Study ID Numbers: EFC12456, 2012-001524-35, U1111-1128-5517
Study First Received: September 7, 2012
Results First Received: March 24, 2015
Last Updated: April 22, 2015
Health Authority: United States: Food and Drug Administration