Comparison of Glycemic Control Achieved With 2 Different Needles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572052
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

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 Type : Interventional  (Clinical Trial)
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 : December 2002
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Subject preference and handling
  2. Frequency of hypoglycaemic episodes
  3. Quality of Life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00572052

United States, California
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, New Jersey
Novo Nordisk Investigational Site
Berlin, New Jersey, United States, 08009
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, Ohio
Novo Nordisk Investigational Site
Kettering, Ohio, United States, 45429
United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S Identifier: NCT00572052     History of Changes
Other Study ID Numbers: NEEDLEN-2168
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

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