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6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes (PRESCHOOL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00993473
First received: October 9, 2009
Last updated: June 25, 2012
Last verified: June 2012
Results First Received: March 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: Insulin glargine (HOE901)
Drug: Neutral Protamine Hagedorn (NPH) insulin
Drug: Insulin lispro

  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
The study was conducted in 61 centers (72 were initiated) in 16 countries between October 15, 2009 and March 30, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 165 patients were screened and 125 were randomized. Forty patients (24.2%) failed the screening selection process, mainly due to noncompliance with the study required Continuous Glucose Monitoring (CGM) performance and other procedures.

Reporting Groups
  Description
Lantus (Insulin Glargine)

Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.

Dose: titrated to achieve glycemic targets as described in protocol section.

NPH Insulin

Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.

Dose: titrated to achieve glycemic targets as described in protocol section.


Participant Flow:   Overall Study
    Lantus (Insulin Glargine)   NPH Insulin
STARTED   61 [1]   64 [2] 
COMPLETED   57   54 
NOT COMPLETED   4   10 
Adverse Event                0                2 
Protocol Violation                1                2 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                5 
Technical problem with CGM device                0                1 
Family event                1                0 
[1] 61 patients randomized to Lantus but 62 patients treated with Lantus due to a dispensation's error
[2] 64 patients randomized to NPH but only 63 patients treated with NPH due to a dispensation's error



  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.
No text entered.

Reporting Groups
  Description
Lantus (Insulin Glargine)

Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.

Dose: titrated to achieve glycemic targets as described in protocol section.

NPH Insulin

Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.

Dose: titrated to achieve glycemic targets as described in protocol section.

Total Total of all reporting groups

Baseline Measures
    Lantus (Insulin Glargine)   NPH Insulin   Total
Overall Participants Analyzed 
[Units: Participants]
 61   64   125 
Age 
[Units: Years]
Mean (Standard Deviation)
 4.3  (0.9)   4.1  (1.0)   4.2  (1.0) 
Age 
[Units: Years]
Median (Full Range)
 5.0 
 (2 to 5) 
 4.0 
 (1 to 6) 
 4.0 
 (1 to 6) 
Age, Customized 
[Units: Participants]
     
<= 3 years   10   17   27 
> 3 years   51   47   98 
Gender, Customized 
[Units: Participants]
     
Male   32   30   62 
Female   29   34   63 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian/White   53   48   101 
Black   2   2   4 
Asian/Oriental   4   11   15 
Other   2   3   5 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic   17   13   30 
Non Hispanic   44   51   95 
Duration of diabetes 
[Units: Years]
Mean (Standard Deviation)
 2.12  (1.16)   2.12  (1.01)   2.12  (1.08) 
Duration of diabetes 
[Units: Years]
Median (Full Range)
 1.63 
 (1.0 to 5.3) 
 2.05 
 (1.0 to 4.9) 
 1.81 
 (1.0 to 5.3) 
Treated by bolus insulin at baseline 
[Units: Participants]
     
Yes   54   58   112 
No   7   6   13 
Treated by basal insulin at baseline 
[Units: Participants]
     
Yes   58   57   115 
No   3   7   10 
Treated by mixed (bolus & basal) insulin at baseline 
[Units: Participants]
     
Yes   5   8   13 
No   56   56   112 
Number of daily basal insulin injections at baseline 
[Units: Participants]
     
 32   41   73 
 21   15   36 
>=3   5   1   6 
Not treated with basal insulin at baseline   3   7   10 
Total daily dose of basal insulin injection at baseline 
[Units: Participants]
     
Analyzed   57   57   114 
Not treated by basal insulin or missing   4   7   11 
Total daily dose of basal insulin injection at baseline 
[Units: International Units]
Mean (Standard Deviation)
 7.29  (4.11)   7.61  (4.77)   7.45  (4.43) 
Total daily dose of basal insulin injection at baseline 
[Units: International Units]
Median (Full Range)
 6.00 
 (2.0 to 24.0) 
 6.00 
 (1.5 to 24.0) 
 6.00 
 (1.5 to 24.0) 
Total daily dose of bolus insulin injection at baseline 
[Units: Participants]
     
Analyzed   52   57   109 
Not treated by bolus insulin or missing   9   7   16 
Total daily dose of bolus insulin injection at baseline 
[Units: International Units]
Mean (Standard Deviation)
 7.14  (3.64)   7.98  (7.20)   7.58  (5.77) 
Total daily dose of bolus insulin injection at baseline 
[Units: International Units]
Median (Full Range)
 7.75 
 (1.3 to 16.0) 
 7.00 
 (0.8 to 45.0) 
 7.00 
 (0.8 to 45.0) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)   [ Time Frame: 6 months ]

2.  Secondary:   Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)   [ Time Frame: 6 months ]

3.  Secondary:   Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years   [ Time Frame: 6 months ]

4.  Secondary:   Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of "All Hypoglycemia" Episodes Divided by the Total Duration of the On-treatment Period in Years   [ Time Frame: 6 months ]

5.  Secondary:   Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years   [ Time Frame: 6 months ]

6.  Secondary:   Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years   [ Time Frame: 6 months ]

7.  Secondary:   Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment   [ Time Frame: baseline, 6 months ]

8.  Secondary:   Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)   [ Time Frame: baseline, 6 months ]

9.  Secondary:   Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit   [ Time Frame: 6 months ]

10.  Secondary:   Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment   [ Time Frame: baseline, 6 months ]

11.  Other Pre-specified:   Number of Patients With Different Types of Hypoglycemia Events   [ Time Frame: 6 months ]

12.  Other Pre-specified:   Percent of Blood Glucose (BG) Within the Range of 70 – 180 mg/dL (3.9-10 mmol/L)   [ Time Frame: 6 months ]

13.  Other Pre-specified:   Blood Glucose Variability Based on All On-treatment CGMS Values   [ Time Frame: 6 months ]

14.  Other Pre-specified:   Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values   [ Time Frame: 6 months ]

15.  Post-Hoc:   Event Rate of "All Confirmed Low CGMS Excursions" (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)   [ Time Frame: 6 months ]

16.  Post-Hoc:   Event Rate of "All Confirmed Low FSBG" (Individual Component of the Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)   [ Time Frame: 6 months ]


  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
There are numerous potential biases that could affect the timing and frequency of performance of sporadic FSBG, such as mealtime dosing and choice of bolus insulin dose, stability and familiarity with insulin regimens, and parental anxiety levels.


  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-aventis
e-mail: Contact_US@sanofi.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00993473     History of Changes
Other Study ID Numbers: EFC11202
2009-011231-12 ( EudraCT Number )
Study First Received: October 9, 2009
Results First Received: March 28, 2012
Last Updated: June 25, 2012
Health Authority: United States: Food and Drug Administration