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

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ClinicalTrials.gov Identifier: NCT01707134
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin aspart Drug: human soluble insulin Drug: insulin NPH Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 753 participants
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
Study Start Date : September 1997
Actual Primary Completion Date : May 2000
Actual Study Completion Date : May 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of hypoglycaemic events

Secondary Outcome Measures :
  1. Occurrence of adverse events
  2. Incidence of hypoglycaemic episodes
  3. Standard safety parameters: Haematology and biochemistry
  4. HbA1c (glycosylated haemoglobin)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01707134     History of Changes
Other Study ID Numbers: ANA/DCD/050
First Posted: October 16, 2012    Key Record Dates
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