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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01658579
First received: July 26, 2012
Last updated: May 5, 2015
Last verified: May 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 (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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
HOE901-U300 Morning Then Evening 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 Evening Then Morning 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 Morning Then Evening 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 Evening Then Morning 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).

Participant Flow for 2 periods

Period 1:   Treatment Period A
    HOE901-U300 Morning Then Evening     HOE901-U300 Evening Then Morning     Lantus Morning Then Evening     Lantus Evening Then Morning  
STARTED     15     15     15     14  
COMPLETED     14     15     14     13  
NOT COMPLETED     1     0     1     1  
Unspecified                 0                 0                 1                 1  
Adverse Event                 1                 0                 0                 0  

Period 2:   Treatment Period B
    HOE901-U300 Morning Then Evening     HOE901-U300 Evening Then Morning     Lantus Morning Then Evening     Lantus Evening Then Morning  
STARTED     14     15     14     13  
COMPLETED     14     15     14     12  
NOT COMPLETED     0     0     0     1  
Unspecified                 0                 0                 0                 1  



  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 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.

Reporting Groups
  Description
HOE901-U300 Morning Then Evening 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 Evening Then Morning 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 Morning Then Evening 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 Evening Then Morning 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 Total of all reporting groups

Baseline Measures
    HOE901-U300 Morning Then Evening     HOE901-U300 Evening Then Morning     Lantus Morning Then Evening     Lantus Evening Then Morning     Total  
Number of Participants  
[units: participants]
  15     15     15     14     59  
Age  
[units: years]
Mean (Standard Deviation)
  43.6  (14.6)     46.2  (15.9)     39.7  (12.5)     47.6  (14.1)     44.2  (14.3)  
Gender  
[units: participants]
         
Female     11     2     4     10     27  
Male     4     13     11     4     32  
Body Mass Index (BMI)  
[units: kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
  27.5  (4.9)     27.4  (5.0)     28.3  (6.2)     26.1  (5.1)     27.3  (5.3)  
Glycated Hemoglobin (HbA1c)  
[units: participants]
         
Less Than (<) 8     11     14     12     12     49  
Greater Than or Equal to (>=) 8     4     1     3     2     10  
Duration of Diabetes  
[units: years]
Median (Full Range)
  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]
[units: units per kilogram (U/kg)]
Mean (Standard Deviation)
  0.309  (0.086)     0.283  (0.088)     0.341  (0.100)     0.267  (0.055)     0.301  (0.087)  
Total Insulin Daily Dose [2]
[units: U/kg]
Mean (Standard Deviation)
  0.600  (0.237)     0.620  (0.179)     0.677  (0.204)     0.513  (0.115)     0.603  (0.193)  
[1] Number of participants analyzed for this baseline characteristics =15, 14, 15, and 13 for each reporting group, respectively.
[2] Number of participants analyzed for this baseline characteristics = 13, 13, 13, 13 for each reporting group, respectively.



  Outcome Measures
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1.  Primary:   Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])   [ Time Frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) ]

2.  Secondary:   Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])   [ Time Frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) ]

3.  Secondary:   Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])   [ Time Frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) ]

4.  Secondary:   Evaluation of Diurnal Glucose Exposure, Variability, and Stability   [ Time Frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) ]

5.  Secondary:   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   [ Time Frame: Weeks 7-8 in Period A and Weeks 15-16 in Period B ]

6.  Secondary:   Change in HbA1c From Baseline to Week 8 and 16   [ Time Frame: Baseline, Week 8, 16 ]

7.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16   [ Time Frame: Baseline, Week 8, 16 ]

8.  Secondary:   Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16   [ Time Frame: Baseline, Week 8, 16 ]

9.  Secondary:   Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16   [ Time Frame: Baseline, Week 8, 16 ]

10.  Secondary:   Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16   [ Time Frame: Up to Week 16 ]


  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: NCT01658579     History of Changes
Other Study ID Numbers: PDY12777, U1111-1130-3593
Study First Received: July 26, 2012
Results First Received: March 24, 2015
Last Updated: May 5, 2015
Health Authority: United States: Food and Drug Administration