Comparison of Glycemic Control Achieved With 2 Different Needles
NCT ID: NCT00572052
Last Updated: 2017-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
62 participants
INTERVENTIONAL
2002-12-31
2003-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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NovoFine® needle 6 mm
Ultra-Fine needle 12.7 mm
Eligibility Criteria
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Inclusion Criteria
* 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
* Self-mixing insulin
* Unwillingness to monitor blood glucose
* Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures
18 Years
60 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Berlin, New Jersey, United States
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States
Novo Nordisk Investigational Site
Kettering, Ohio, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NEEDLEN-2168
Identifier Type: -
Identifier Source: org_study_id
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