Comparison of Glycemic Control Achieved With 2 Different Needles
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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
DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Delivery Systems
Device: NovoFine® needle 6 mmDevice: Ultra-Fine needle 12.7 mm
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 :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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%
Severe, uncontrolled hypertension
Unwillingness to monitor blood glucose
Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures