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Comparison of Glycemic Control Achieved With 2 Different Needles

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NovoFine® needle 6 mm
Ultra-Fine needle 12.7 mm
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Subject preference and handling
Frequency of hypoglycaemic episodes
Quality of Life

Full Information

First Posted
December 4, 2007
Last Updated
January 18, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00572052
Brief Title
Comparison of Glycemic Control Achieved With 2 Different Needles
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
NovoFine® needle 6 mm
Intervention Type
Device
Intervention Name(s)
Ultra-Fine needle 12.7 mm
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Subject preference and handling
Title
Frequency of hypoglycaemic episodes
Title
Quality of Life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15598483
Citation
Schwartz S, Hassman D, Shelmet J, Sievers R, Weinstein R, Liang J, Lyness W. A multicenter, open-label, randomized, two-period crossover trial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge x 6 mm needle versus a 29 gauge x 12.7 mm needle in obese patients with diabetes mellitus. Clin Ther. 2004 Oct;26(10):1663-78. doi: 10.1016/j.clinthera.2004.10.007.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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Comparison of Glycemic Control Achieved With 2 Different Needles

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