Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy (EDITION II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01499095
First received: December 16, 2011
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 2 Diabetes Mellitus
Interventions: Drug: Lantus (Insulin glargine)
Drug: HOE901-U300 (new formulation of 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 1250 participants were screened, of whom 439 participants were screen failure and 811 participants were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following the main 6 month treatment period, eligible participants previously using HOE901-U300 were randomized (1:1) in a substudy and continued with fixed-dosing (every 24 hours) or started a adaptable-dosing (at intervals of 24 +/- 3 hours) regimen for 3 Months (Month 6 to 9).

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 oral antidiabetic drug(s).
Lantus Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).

Participant Flow:   Overall Study
    HOE901-U300     Lantus  
STARTED     404     407  
Treated     403     406  
Participated in Substudy     89 [1]   0  
Modified Intent-to-Treat Population     403 [2]   405 [2]
COMPLETED     315     314  
NOT COMPLETED     89     93  
Randomized But Not Treated                 1                 1  
Adverse Event                 12                 7  
Lack of Efficacy                 2                 1  
Protocol Violation                 6                 7  
Received Rescue Therapy                 32                 40  
Diverse Reasons                 22                 25  
Lost to Follow-up                 6                 4  
Insulin Dropped Below Authorized Dose                 0                 5  
Hypoglycemia                 3                 1  
Diagnosed With Type 1 Diabetes Mellitus                 2                 1  
Change in Injection Schedule                 2                 0  
Perceived Lack of Efficacy                 1                 1  
[1] 45 participants received adaptable dosing regimen and 44 participants received fixed dosing regimen
[2] 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 for 12 months in combination with oral antidiabetic drug(s).
Lantus Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
Total Total of all reporting groups

Baseline Measures
    HOE901-U300     Lantus     Total  
Number of Participants  
[units: participants]
  404     407     811  
Age  
[units: years]
Mean ± Standard Deviation
  57.9  ± 9.1     58.5  ± 9.2     58.2  ± 9.2  
Gender  
[units: participants]
     
Female     217     222     439  
Male     187     185     372  
Body Mass Index (BMI)  
[units: kilogram per square meter]
Mean ± Standard Deviation
  34.8  ± 6.6     34.8  ± 6.1     34.8  ± 6.4  
Duration of Diabetes [1]
[units: years]
Median ( Full Range )
  11.6  
  ( 1 to 54 )  
  11.7  
  ( 1 to 51 )  
  11.7  
  ( 1 to 54 )  
Basal Insulin Daily Dose [2]
[units: units per kilogram]
Mean ± Standard Deviation
  0.660  ± 0.221     0.681  ± 0.253     0.671  ± 0.238  
Glycated Hemoglobin A1c (HbA1c)  
[units: participants]
     
Less Than (<) 8%     144     146     290  
Greater Than or Equal to (>=) 8%     260     261     521  
[1] Number of participants analyzed for this baseline characteristics = 403 and 407 in HOE901­U300 and Lantus arm, respectively.
[2] Number of participants analyzed for this baseline characteristics = 378 and 382 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 ]

2.  Secondary:   Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint   [ Time Frame: Week 9 Up to Month 6 ]

3.  Secondary:   Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

4.  Secondary:   Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

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

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

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

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

9.  Secondary:   Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint   [ Time Frame: Baseline, Month 6 ]

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

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

12.  Other Pre-specified:   Change in HbA1c From Month 6 to Month 9   [ Time Frame: Month 6 up to Month 9 ]


  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


Publications of Results:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01499095     History of Changes
Other Study ID Numbers: EFC11629, 2010-023770-39, U1111-1118-6943
Study First Received: December 16, 2011
Results First Received: March 24, 2015
Last Updated: April 22, 2015
Health Authority: United States: Food and Drug Administration