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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: October 10, 2012
Last updated: January 3, 2017
Last verified: January 2017
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.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: insulin aspart
Drug: human soluble insulin
Drug: insulin NPH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of hypoglycaemic events

Secondary Outcome Measures:
  • Occurrence of adverse events
  • Incidence of hypoglycaemic episodes
  • Standard safety parameters: Haematology and biochemistry
  • HbA1c (glycosylated haemoglobin)

Enrollment: 753
Study Start Date: September 1997
Study Completion Date: May 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin aspart Drug: insulin aspart
Injected subcutaneously (s.c, under the skin) as meal time insulin
Drug: insulin NPH
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
Active Comparator: human insulin Drug: human soluble insulin
Injected subcutaneously (s.c, under the skin) as meal time insulin
Drug: insulin NPH
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
  Contacts and Locations
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Please refer to this study by its identifier: NCT01707134

  Show 80 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01707134     History of Changes
Other Study ID Numbers: ANA/DCD/050
Study First Received: October 10, 2012
Last Updated: January 3, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 28, 2017