Comparison of Glycemic Control Achieved With 2 Different Needles

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

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.

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