Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500

Biodel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Humalog Mix 75/25; Drug: BIOD-531; Drug: Humulin R U-500

Study type: Interventional

Funder types: Industry

Identifiers

NCT02212951

3-152

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

12 participants in 4 patient groups

BIOD-531 pre-meal

Experimental group

Description:

Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast

Treatment:

Drug: BIOD-531

Humalog Mix 75/25 pre-meal

Active Comparator group

Description:

Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast

Treatment:

Drug: Humalog Mix 75/25

Humulin R U-500

Active Comparator group

Description:

Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast

Treatment:

Drug: Humulin R U-500

BIOD-531 post-meal

Experimental group

Description:

Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast

Treatment:

Drug: BIOD-531