Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin R U-500 and Humalog Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day
The study is to compare meal time glucose control associated with BIOD-531, a rapidly
absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.
absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.
Inclusion Criteria:
- Age 18-65
- BMI > 25 kg/m2
- Type 2 Diabetes Mellitus
- HbA1c < 10.0%
- Subject uses 50-200 units of insulin/day
Exclusion Criteria:
- Type 1 Diabetes Mellitus
- History of bariatric surgery
- Corticosteroid therapy
- Significant cardiovascular or other major organ disease
- Females who are breast feeding or pregnant
- A sexually active person not using adequate contraceptive methods
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