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

A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin® R U-500 and Humalog® Mix75/25™ in Subjects With Type 2 DM Who Are Treated With ≥ 150 Units of Insulin Per Day

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02324309

Enrollment

Registered

2014-12-24

Start date

2014-05-31

Completion date

Unknown

Last updated

2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

DRUGBIOD-531

DRUGHumalog Mix 75/25

DRUGHumulin R U-500

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Post-breakfast glucose exposure (AUC)	0-330 minutes

Secondary

Measure	Time frame
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)	0-330 and 660-1020 minutes
Insulin exposure (AUC)	0-1440 minutes
Maximal insulin concentration	0-330 and 660-1020 minutes
Post-lunch and post-dinner glucose exposures (AUC)	330-660 and 660-1020 minutes
Injection site toleration (VAS and severity scales)	30 and 690 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026