Comparison of Glycemic Control Achieved With 2 Different Needles - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00572052

Purpose

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	Intervention	Phase
Diabetes Mellitus	Device: NovoFine needle 6 mm Device: Ultra-Fine needle 12.7 mm	Phase IV

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Comparison of Glycaemic Control Achieved With a 31 Gauge x 6 mm Needle vs. a 29 Gauge x 12.7 mm Needle in Obese Subjects With Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures:

Subject preference and handling
Frequency of hypoglycaemic episodes
Quality of Life

Estimated Enrollment:	55
Study Start Date:	December 2002

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572052

Locations

United States, California
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Clinical Trial Call Center
Berlin, New Jersey, United States, 08009
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Kettering, Ohio, United States, 45429
United States, Texas
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

William Lyness, PhD

Novo Nordisk

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NEEDLEN-2168
Study First Received:	December 4, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00572052
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009