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

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00095446

Purpose

This trial has been designed 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 Mellitus	Drug: insulin aspart	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Treatment satisfaction with insulin pump therapy

Secondary Outcome Measures:

body weight
Insulin dose
Overall glycemic control
number and types of infusion sets used.
infusion set in-use times

Estimated Enrollment:

500

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

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	ANA-2190
Study First Received:	November 4, 2004
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00095446
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

Diabetes Mellitus
Diabetes

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009