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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy (EDITION III)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01676220
First received: August 28, 2012
Last updated: May 28, 2015
Last verified: May 2015
History of Changes
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 2 Diabetes Mellitus
Interventions: Drug: HOE901-U300 (new formulation of insulin glargine)
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 1396 participants were screened, of whom 518 participants were screen failure and 878 participants were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
HOE901-U300 HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus (Insulin Glargine) Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).

Participant Flow:   Overall Study
    HOE901-U300     Lantus (Insulin Glargine)  
STARTED     439     439  
Treated     435     438  
Modified Intent-To-Treat Population     432 [1]   430 [1]
COMPLETED     337     314  
NOT COMPLETED     102     125  
Randomized But Not Treated                 4                 1  
Adverse Event                 10                 8  
Lack of Efficacy                 2                 5  
Protocol Violation                 11                 12  
Received Rescue Therapy                 14                 22  
Personal Reason                 34                 45  
Lost to Follow-up                 11                 18  
Selection Criterion/Protocol Violation                 9                 9  
Site Closure/Site Withdrawal                 1                 4  
Perceived Lack of Efficacy                 3                 1  
Non Serious Hypoglycemia                 2                 0  
No More Need of Insulin                 1                 0  
[1] Participants who received at least 1 dose of drug, had both baseline, at least 1 post­baseline 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 for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Total Total of all reporting groups

Baseline Measures
    HOE901-U300     Lantus     Total  
Number of Participants  
[units: participants]
 		  439     439     878  
Age  
[units: years]
Mean (Standard Deviation) 		  58.2  (9.9)     57.2  (10.3)     57.7  (10.1)  
Gender  
[units: participants]
 		     
Female     186     185     371  
Male     253     254     507  
Body Mass Index (BMI)  
[units: kilogram per square meter]
Mean (Standard Deviation) 		  32.8  (6.9)     33.2  (6.6)     33.0  (6.7)  
Duration of Diabetes [1]
[units: years]
Mean (Standard Deviation) 		  10.11  (6.49)     9.57  (6.22)     9.84  (6.36)  
Basal Insulin Daily Dose [2]
[units: units per kilogram (U/kg)]
Mean (Standard Deviation) 		  0.193  (0.027)     0.193  (0.034)     0.193  (0.031)  
Glycated Hemoglobin A1c (HbA1c)  
[units: participants]
 		     
Less Than (<) 8%     141     142     283  
Greater Than or Equal to (>=) 8%     298     297     595  
[1] Number of participants analyzed for this baseline characteristics = 435 and 436 in HOE901-U300 and Lantus arm, respectively.
[2] Number of participants analyzed for this baseline characteristics = 432 and 436 in HOE901-U300 and Lantus arm, respectively.



  Outcome Measures
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1.  Primary:   Change in HbA1c From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]
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2.  Secondary:   Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6   [ Time Frame: Week 9 Up to Month 6 ]
  Show Outcome Measure 2

3.  Secondary:   Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]
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4.  Secondary:   Variability of Preinjection SMPG at Month 6 Endpoint   [ Time Frame: Month 6 ]
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5.  Secondary:   Percentage of Participants With HbA1c <7% at Month 6   [ Time Frame: Month 6 ]
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6.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]
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7.  Secondary:   Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 7

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

9.  Secondary:   Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]
  Show Outcome Measure 9

10.  Secondary:   Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]
  Show Outcome Measure 10

11.  Secondary:   Change in Daily Basal Insulin Dose From Baseline to Month 6   [ Time Frame: Baseline, Month 6 ]
  Show Outcome Measure 11

12.  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 ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12   [ Time Frame: Up to 12 months ]
  Show Outcome Measure 13


  Serious Adverse Events
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  Other Adverse Events
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  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


Publications of Results:


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01676220     History of Changes
Other Study ID Numbers: EFC12347
2012-000146-35 ( EudraCT Number )
U1111-1124-5261 ( Other Identifier: UTN )
Study First Received: August 28, 2012
Results First Received: March 24, 2015
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration