Clinical Trial Results:
A Study of Effectiveness and Safety of Apidra in Combination With Lantus Therapy in Basal-bolus Insulin Regimen in Inadequately Controlled Children and Adolescents With Type 1 Diabetes in the Russian Federation.
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Summary
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EudraCT number |
2014-004639-38 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
18 Oct 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Apr 2016
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First version publication date |
26 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
APIDR_L_04884
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01202474 | ||
WHO universal trial number (UTN) |
U1111-1116-8645 | ||
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Sponsors
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Sponsor organisation name |
Sanofi-aventis Russia
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Sponsor organisation address |
Tverskaya str., 22, "Summit Business Centre” , Moscow, Russian Federation, 125009
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Public contact |
Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Mar 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Oct 2012
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the percentage of subjects achieving glycosylated hemoglobin (HbA1c) level < 8% (in subjects of 6-12 years old) and HbA1c level < 7.5% (in subjects of 13-17 year old) at 6 and 12 months of treatment.
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Protection of trial subjects |
The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 May 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Russian Federation: 90
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Worldwide total number of subjects |
90
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
32
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Adolescents (12-17 years) |
58
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was performed at 8 centers in the Russian Federation. A total of 100 subjects were screened between 17 May 2011 to 13 Oct 2011. | ||||||||||||
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Pre-assignment
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Screening details |
Of 100 screened subjects, 90 subjects were treated. 10 subjects were excluded due to protocol noncompliance linked to the Investigational product | ||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Insulin Glulisine + Insulin Glargine | ||||||||||||
Arm description |
Insulin Glulisine in combination with insulin Glargine for 12 month. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Insulin Glargine
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Investigational medicinal product code |
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Other name |
Lantus
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Insulin Glargine, according to recommendations of treatment in children and adolescents once a daily.
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Investigational medicinal product name |
Insulin Glulisine
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Investigational medicinal product code |
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Other name |
Apidra®
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Insulin Glulisine, as per Physician's practice, before meal (0-15) minutes, or within 20 minutes after a meal start.
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Baseline characteristics reporting groups
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Reporting group title |
Insulin Glulisine + Insulin Glargine
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Reporting group description |
Insulin Glulisine in combination with insulin Glargine for 12 month. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Insulin Glulisine + Insulin Glargine
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Reporting group description |
Insulin Glulisine in combination with insulin Glargine for 12 month. | ||
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End point title |
Percentage of Subject Who Achieved HbA1c Level < 8% in Subjects 6-12 Years Old [1] | ||||||||||||
End point description |
Analysis was performed in efficacy population included all treated subjects. Number of subjects analysed = subjects from efficacy population at age 6-12 years.
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End point type |
Primary
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End point timeframe |
At 6 and 12 month
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm study |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Who Achieved HbA1c Level < 7,5% in Subjects 13 - 17 Years Old [2] | ||||||||||||
End point description |
Analysis was performed in efficacy population. Number of subjects analysed = subjects from efficacy population at age 13-17 years.
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End point type |
Primary
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End point timeframe |
At 6 and 12 month
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Single arm study |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change in HbA1c | ||||||||||||||
End point description |
Analysis was performed on efficacy population.
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End point type |
Secondary
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End point timeframe |
Baseline, month 6, month 12
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Change in Daily Dose of Insuline Glargine and Glulisine | ||||||||||||||||||||
End point description |
Analysis was performed on efficacy population.
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End point type |
Secondary
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End point timeframe |
Baseline, month 6, month 12
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Rate of Hypoglycemia Per Subject | ||||||||
End point description |
Hypoglycemia episodes in three categories: symptomatic, symptom-free and severe hypoglycemia. Analysis was carried out on safety population included all subjects who received at least one dose of insulin glargine.
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End point type |
Secondary
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End point timeframe |
From baseline up to 12 month
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (12 month) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
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Adverse event reporting additional description |
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (after the first study drug intake until 24 hrs after last drug).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.3
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Reporting groups
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Reporting group title |
Insulin Glulisine + Insulin Glargine
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Reporting group description |
Insulin Glulisine in combination with insulin Glargine for 12 month. | ||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Jan 2011 |
To use insulin glulisin (Apidra®) as the studied therapy making use of the prefilled disposable syringe SoloStar® 100 U/ml instead of the earlier planned reusable syringe OptiClick®.
To change the date to conduct the study due to the later beginning of the subjects enrollment. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
