Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old. (Lantus-P-CN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01223131
First received: October 15, 2010
Last updated: March 31, 2014
Last verified: March 2014

October 15, 2010
March 31, 2014
February 2011
March 2014   (final data collection date for primary outcome measure)
Absolute change of glycosylated hemoglobin (HbA1c) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01223131 on ClinicalTrials.gov Archive Site
  • Percentage of patients reaching HbA1c < 7.5% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in Fasting Blood Glucose (FBG) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in nocturnal Blood Glucose (BG) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in total insulin dose and basal insulin dose [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia. [ Time Frame: during 24-week treatment period ] [ Designated as safety issue: Yes ]
  • Anti-glargine and anti-human insulin antibody assessment [ Time Frame: at screening, week 4, week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years

Primary Objective:

6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years.

Secondary Objectives:

  • To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:

    • Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c < 7.5%,
    • Fasting blood glucose (FBG),
    • Nocturnal blood glucose (BG),
    • 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values,
    • Daily total insulin dose and basal insulin dose,
    • Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
  • To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
  • To assess anti-insulin and anti-glargine antibody development in both groups.
  • To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing

The study duration for each patient is 28 weeks +/- 7 day broken down as follows:

  • Screening phase: up to 2 weeks
  • Run-in phase: 1 week
  • Treatment phase: 24 weeks
  • Follow-up: 1 week
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Drug: Insulin glargine (HOE901)

    Pharmaceutical form:aqueous solution for injection

    Route of administration: Subcutaneous

  • Drug: NPH insulin

    Pharmaceutical form:aqueous solution for injection

    Route of administration: Subcutaneous

  • Experimental: Insulin glargine
    injection once daily at bedtime
    Intervention: Drug: Insulin glargine (HOE901)
  • Active Comparator: NPH insulin
    injection once daily at bedtime or twice daily in the morning and at bedtime
    Intervention: Drug: NPH insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

- Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening.

Exclusion criteria:

  • Treatment with oral or parenteral glucose-lowering medications other than insulin.
  • HbA1c < 7% or > 12 % at screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01223131
EFC11681, U1111-1116-3661
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP