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Completed

NCT Number: NCT01490112

Surveillance Study of NovoRapid® for New Drug Re-examination

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Seoul, 137-920, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)

Treatment and study plan

insulin aspart

Drug

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

Primary outcomes

  1. Change in weight

Secondary outcomes

  1. Fasting blood glucose (FBG)

  2. HbA1c (glycosylated haemoglobin)

  3. Adverse events: Serious and non-serious

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Regulatory Post Marketing Surveillance Study of NovoRapid for New Drug Re-examination

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 12, 2011
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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