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)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01223131

EFC11681

U1111-1116-3661 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 162 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Insulin glargine

Experimental group

Description:

injection once daily at bedtime

Treatment:

Drug: Insulin glargine (HOE901)

NPH insulin

Active Comparator group

Description:

injection once daily at bedtime or twice daily in the morning and at bedtime

Treatment:

Drug: NPH insulin