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NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes

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.
ClinicalTrials.gov Identifier: NCT00095446
Recruitment Status : Completed
First Posted : November 5, 2004
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin aspart Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 513 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open-Label, Multi Center, Clinical Trial: External Continuous Subcutaneous Infusion of Insulin Using Insulin Aspart (NovoLog®) in Subjects With Type 1 and Insulin Requiring Type 2 Diabetes
Study Start Date : July 2004
Primary Completion Date : March 2005
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Treatment satisfaction with insulin pump therapy

Secondary Outcome Measures :
  1. body weight
  2. Insulin dose
  3. Overall glycemic control
  4. number and types of infusion sets used.
  5. infusion set in-use times

Eligibility Criteria

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:

  • People with Type I or Type II Diabetes
  • 18 Years or Older.
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): NCT00095446


Locations
United States, New Jersey
Novo Nordisk Investigational Site
Princeton, New Jersey, United States, 08540
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: NCT00095446     History of Changes
Other Study ID Numbers: ANA-2190
First Posted: November 5, 2004    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by Novo Nordisk A/S:
Diabetes Mellitus
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs