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

Type 1 Diabetes Mellitus Clinical Trial

— Lantus-P-CN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223131
• Other study ID #: EFC11681
• Secondary ID: U1111-1116-3661
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2010
• Last updated: March 31, 2014
• Start date: February 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine (HOE901)
Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous
• NPH insulin
Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous

Locations

Country	Name	City	State
China	Investigational Site Number 156001	Beijing
China	Investigational Site Number 156006	Beijing
China	Investigational Site Number 156007	Beijing
China	Investigational Site Number 156009	Changsha
China	Investigational Site Number 156008	Guangzhou
China	Investigational Site Number 156004	Hangzhou
China	Investigational Site Number 156005	Shanghai
China	Investigational Site Number 156016	Shanghai
China	Investigational Site Number 156019	Taiyuan
China	Investigational Site Number 156002	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change of glycosylated hemoglobin (HbA1c)		from baseline to week 24	No
Secondary	Percentage of patients reaching HbA1c < 7.5%		at week 24	No
Secondary	Change in Fasting Blood Glucose (FBG)		from baseline to week 24	No
Secondary	Change in nocturnal Blood Glucose (BG)		from baseline to week 24	No
Secondary	Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)		from baseline to week 24	No
Secondary	Change in total insulin dose and basal insulin dose		from baseline to week 24	No
Secondary	Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.		during 24-week treatment period	Yes
Secondary	Anti-glargine and anti-human insulin antibody assessment		at screening, week 4, week 24	No