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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date July 2004
Completion Date March 2005
Primary Completion Date March 2005
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Treatment satisfaction with insulin pump therapy
Secondary Outcome
Measure Time Frame
body weight
Insulin dose
Overall glycemic control
number and types of infusion sets used.
infusion set in-use times
Enrollment 513
Condition
Intervention

Intervention Type: Drug

Intervention Name: insulin aspart

Eligibility

Criteria:

Inclusion Criteria:

- People with Type I or Type II Diabetes

- 18 Years or Older.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR,1452) Study Director Novo Nordisk A/S
Location
Facility: Novo Nordisk Investigational Site
Location Countries

United States

Verification Date

January 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov