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

• ClinicalTrials.gov Identifier: NCT00095446
• Recruitment Status: Completed
• First Posted: November 5, 2004
• Last Update Posted: January 4, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: November 4, 2004
• First Posted Date: November 5, 2004
• Last Update Posted Date: January 4, 2017
• Study Start Date: July 2004
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2005): Treatment satisfaction with insulin pump therapy
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 26, 2008)

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

Original Secondary Outcome Measures (submitted: June 23, 2005)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Diabetes
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

• Intervention: Drug: insulin aspart
• Study Arms: Not Provided
• Publications *: Wittlin SD, Marcus AO, Weng CS, Howard CP, Schorr AB; CONTROL Study Group. Evaluation of treatment satisfaction associated with the use of insulin aspart in continuous subcutaneous insulin infusion. Diabetes Technol Ther. 2008 Feb;10(1):1-10. doi: 10.1089/dia.2007.0234.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 13, 2009): 513
• Original Enrollment (submitted: June 23, 2005): 500
• Actual Study Completion Date: March 2005
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00095446
• Other Study ID Numbers: ANA-2190
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Not Provided
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Global Clinical Registry (GCR,1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: January 2017