BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance

Biodel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02324309

3-151

Details and patient eligibility

About

The study is designed 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 in patients with diabetes and severe insulin resistance.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI > 25 kg/m2
• Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening
• HbA1c < 10.0%

Exclusion criteria

• 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

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12 participants in 4 patient groups

BIOD-531 pre-meal

Experimental group

Description:

Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.

Treatment:

Drug: BIOD-531

Drug: BIOD-531

Humalog Mix 75/25 pre-meal

Active Comparator group

Description:

Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.

Treatment:

Drug: Humalog Mix 75/25

Humulin R U-500 pre-meal

Active Comparator group

Description:

Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.

Treatment:

Drug: Humulin R U-500

BIOD-531 post-meal

Experimental group

Description:

Subcutaneous injections of 1.2 U/kg 20 minutes after the start of a standardized breakfast and 0.8 U/kg 20 minutes after the start of a standardized dinner.

Treatment:

Drug: BIOD-531

Drug: BIOD-531