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Completed

NCT Number: NCT01707134

Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject must have completed the six month controlled treatment period in trial ANA/DCD/035

Treatment and study plan

insulin aspart

Drug

Injected subcutaneously (s.c, under the skin) as meal time insulin

human soluble insulin

Drug

Injected subcutaneously (s.c, under the skin) as meal time insulin

insulin NPH

Drug

Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin

Primary outcomes

  1. Number of hypoglycaemic events

Secondary outcomes

  1. Occurrence of adverse events

  2. Incidence of hypoglycaemic episodes

  3. Standard safety parameters: Haematology and biochemistry

  4. HbA1c (glycosylated haemoglobin)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic Subjects

Important dates

Study start
1997
Primary completion
2000
Study completion
2000
First posted
Oct 16, 2012
Registry last updated
Jan 4, 2017

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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