Comparison of Glycemic Control Achieved With 2 Different Needles

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

Treatments: Device: NovoFine® needle 6 mm; Device: Ultra-Fine needle 12.7 mm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00572052

NEEDLEN-2168

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)