Comparison of Glycemic Control Achieved With 2 Different Needles
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 1/20/2017 |
| Start Date: | December 2002 |
| End Date: | October 2003 |
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.
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
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