Comparison of Glycemic Control Achieved With 2 Different Needles

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00572052
First received: December 4, 2007
Last updated: October 24, 2013
Last verified: October 2013
  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
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject preference and handling [ Designated as safety issue: No ]
  • Frequency of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Quality of Life [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: December 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  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
Berlin, New Jersey, United States, 08009
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
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 A/S
Investigators
Study Director: William Lyness, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00572052     History of Changes
Other Study ID Numbers: NEEDLEN-2168
Study First Received: December 4, 2007
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014