Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01649570

ANA-1472

Details and patient eligibility

About

This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

Enrollment: 123 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Type 2 diabetes
• Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
• HbA1c below or equal to 11.0%
• BMI (body mass index) below 30 kg/m^2

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Insulin aspart

Experimental group

Treatment:

Drug: insulin aspart