Evaluation of Safety and Parameters of Application Technique

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01516242
• Collaborator: (none)
• Enrollment: 4,819
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 344.3

Study Details

Study Description

Brief Summary

This study is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems	Other: No treatment given

Study Design

• Study Type: Observational
• Actual Enrollment: 4819 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
NovoPen® 4	Other: No treatment given; Collection of data about patients with type 1 diabetes or type 2 diabetes treated with insulin changing their insulin administration from syringe to a insulin delivery system based on completion of questionaire

Outcome Measures

Primary Outcome Measures

1. Number of insulin applications (punctures) []

2. Reasons leading to change of the therapy []

3. Patient satisfaction with NovoPen® 4 insulin delivery system []

Secondary Outcome Measures

1. Adverse reactions []

2. Hypoglycaemia []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diabetes mellitus (type 1 or type 2)

• Treated with insulin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Bratislava		Slovakia	811 05

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01516242
• Other Study ID Numbers: MS236-1926
• First Posted: Jan 24, 2012
• Last Update Posted: Nov 6, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Nov 6, 2016