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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

• Registration Number: NCT00095446
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-11-04
• Study First Submitted QC: 2004-11-04
• Study First Posted: 2004-11-05
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-02
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction with insulin pump therapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Princeton, New Jersey, United States