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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: Insulin glargine (HOE901) (Drug); NPH insulin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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

Clinical Details

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

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

Primary outcome: Absolute change of glycosylated hemoglobin (HbA1c)

Secondary outcome:

Percentage of patients reaching HbA1c < 7.5%

Change in Fasting Blood Glucose (FBG)

Change in nocturnal Blood Glucose (BG)

Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)

Change in total insulin dose and basal insulin dose

Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.

Anti-glargine and anti-human insulin antibody assessment

Detailed 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

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Investigational Site Number 156001, Beijing 100045, China

Investigational Site Number 156006, Beijing 100020, China

Investigational Site Number 156007, Beijing 100730, China

Investigational Site Number 156009, Changsha 410011, China

Investigational Site Number 156008, Guangzhou 510630, China

Investigational Site Number 156004, Hangzhou 310003, China

Investigational Site Number 156005, Shanghai 201102, China

Investigational Site Number 156016, Shanghai 200040, China

Investigational Site Number 156019, Taiyuan 030013, China

Investigational Site Number 156002, Wuhan 430030, China

Additional Information

Starting date: February 2011
Last updated: March 31, 2014

Page last updated: August 23, 2015

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