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NCT00572052 Clinical Trial

Comparison of Glycemic Control Achieved With 2 Different Needles

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00572052
Other study ID # NEEDLEN-2168
Secondary ID
Status Completed
Phase Phase 4
First received December 4, 2007
Last updated January 18, 2017
Start date December 2002
Est. completion date October 2003

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date October 2003
Est. primary completion date October 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NovoFine® needle 6 mm

• Ultra-Fine needle 12.7 mm

Locations
Country Name City State
United States Novo Nordisk Investigational Site Berlin New Jersey
United States Novo Nordisk Investigational Site Kettering Ohio
United States Novo Nordisk Investigational Site Lawrenceville New Jersey
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 gaug — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 12 weeks of treatment
Secondary Subject preference and handling
Secondary Frequency of hypoglycaemic episodes
Secondary Quality of Life
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