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

NCT ID: NCT02324309

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31

Brief Summary

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BIOD-531 pre-meal

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.

Group Type: EXPERIMENTAL

BIOD-531

Intervention Type: DRUG

Humalog Mix 75/25 pre-meal

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.

Group Type: ACTIVE_COMPARATOR

Humalog Mix 75/25

Intervention Type: DRUG

Humulin R U-500 pre-meal

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.

Group Type: ACTIVE_COMPARATOR

Humulin R U-500

Intervention Type: DRUG

BIOD-531 post-meal

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.

Group Type: EXPERIMENTAL

BIOD-531

Intervention Type: DRUG

Interventions

BIOD-531

Intervention Type: DRUG

Humalog Mix 75/25

Intervention Type: DRUG

Humulin R U-500

Intervention Type: DRUG

BIOD-531

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biodel

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie Han-Conrad, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institute for Clinical Research, Inc.

Locations

Profil Institute for Clinical Research, Inc. (PICR)

Chula Vista, California, United States

Countries

United States

Other Identifiers

3-151

Identifier Type: -

Identifier Source: org_study_id