Comparison of Glycemic Control Achieved With 2 Different Needles

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00572052
• Collaborator: (none)
• Enrollment: 62
• Locations: 5
• Duration (Months): 10
• Patients Per Site: 12.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the 29 gauge x 12.7 mm needle in obese subjects with diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems	Device: NovoFine® needle 6 mm; Device: Ultra-Fine needle 12.7 mm	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Glycemic Control Achieved With a 31 Gauge x 6 mm NovoFine® Needle vs. a BD 29 Gauge x 12.7 mm Ultra-Fine® Needle in Subjects With Diabetes Mellitus and a BMI Exceeding 30 kg/m2: An Open Label, Randomized, Two-Period Crossover Study
• Study Start Date: Dec 1, 2002
• Actual Primary Completion Date: Oct 1, 2003
• Actual Study Completion Date: Oct 1, 2003

Outcome Measures

Primary Outcome Measures

1. HbA1c [after 12 weeks of treatment]

Secondary Outcome Measures

1. Subject preference and handling []

2. Frequency of hypoglycaemic episodes []

3. Quality of Life []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diabetes mellitus

• Current treatment with insulin or insulin analogues for the last 6 months

• BMI greater than or equal to 30.0 kg/m2

• Currently injecting in the thigh or abdomen

• HbA1c below 10%

Exclusion Criteria:

• Severe, uncontrolled hypertension

• Self-mixing insulin

• Unwillingness to monitor blood glucose

• Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
2	Novo Nordisk Investigational Site	Berlin	New Jersey	United States	08009
3	Novo Nordisk Investigational Site	Lawrenceville	New Jersey	United States	08648
4	Novo Nordisk Investigational Site	Kettering	Ohio	United States	45429
5	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78229

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: NCT00572052
• Other Study ID Numbers: NEEDLEN-2168
• First Posted: Dec 12, 2007
• Last Update Posted: Jan 19, 2017
• Last Verified: Jan 1, 2017

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

Study Results

No Results Posted as of Jan 19, 2017