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Trial record 5 of 7525 for:    "Diabetes Mellitus"
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NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes

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

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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:
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 aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013