Surveillance Study of NovoRapid® for New Drug Re-examination

Novo Nordisk A/S1,239 enrolled

Overview

This study is conducted in Asia. The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.

Study Type

OBSERVATIONAL

Enrollment

1,239

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

insulin aspartDRUG

Subjects who had a first drug date on NovoRapid® were prescribed to inject insulin aspart using vial, FlexPen, NovoLet or Penfill devices. Injected subcutaneously (s.c., under the skin) immediately before meals for 24 weeks

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)

Locations (1)

Novo Nordisk Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

Change in weight

Secondary Outcomes

Fasting blood glucose (FBG)

HbA1c (glycosylated haemoglobin)

Adverse events: Serious and non-serious

Data from ClinicalTrials.gov

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