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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707134
First Posted: October 16, 2012
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 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: None (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

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707134


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

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01707134     History of Changes
Other Study ID Numbers: ANA/DCD/050
First Submitted: October 10, 2012
First Posted: October 16, 2012
Last Update Posted: January 4, 2017
Last Verified: January 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
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs