Comparison of Glycemic Control Achieved With 2 Different Needles
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 1Delivery SystemsDiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00572052
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method HbA1c after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Subject preference and handling Quality of Life Frequency of hypoglycaemic episodes
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸San Antonio, Texas, United States