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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00095446
First received: November 4, 2004
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Treatment satisfaction with insulin pump therapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body weight [ Designated as safety issue: No ]
  • Insulin dose [ Designated as safety issue: No ]
  • Overall glycemic control [ Designated as safety issue: No ]
  • number and types of infusion sets used. [ Designated as safety issue: No ]
  • infusion set in-use times [ Designated as safety issue: No ]

Enrollment: 513
Study Start Date: July 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People with Type I or Type II Diabetes
  • 18 Years or Older.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095446

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Campbell Howard, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00095446     History of Changes
Other Study ID Numbers: ANA-2190
Study First Received: November 4, 2004
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014