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CompletedNCT00572052Updated Jan 19, 2017

Comparison of Glycemic Control Achieved With 2 Different Needles

A Phase 4 interventional study of NovoFine® needle 6 mm and Ultra-Fine needle 12.7 mm in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 5 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-01-19.

Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Delivery Systems
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 62 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • Severe, uncontrolled hypertension
  • Self-mixing insulin
  • Unwillingness to monitor blood glucose
  • Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Interventions

  • DeviceNovoFine® needle 6 mm
  • DeviceUltra-Fine needle 12.7 mm
06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: after 12 weeks of treatment

Secondary outcomes

  1. Subject preference and handling

  2. Frequency of hypoglycaemic episodes

  3. Quality of Life

07

Study locations

5 sites
  • Novo Nordisk Investigational Site
    Walnut Creek, California 94598, United States
  • Novo Nordisk Investigational Site
    Berlin, New Jersey 08009, United States
  • Novo Nordisk Investigational Site
    Lawrenceville, New Jersey 08648, United States
  • Novo Nordisk Investigational Site
    Kettering, Ohio 45429, United States
  • Novo Nordisk Investigational Site
    San Antonio, Texas 78229, United States
08

References and documents

Publications

  • 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. PubMed 15598483 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00572052
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 12, 2007
Start date
Dec 2002
Primary completion
Oct 2003
Completion
Oct 2003
Last update
Jan 19, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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