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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02212951
Enrollment
12
Registered
2014-08-11
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

Type 2 Diabetes Mellitus

Brief summary

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.

Interventions

DRUGBIOD-531
DRUGHumalog Mix 75/25
DRUGHumulin R U-500

Sponsors

Biodel
Lead SponsorINDUSTRY

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
No

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

Design outcomes

Primary

MeasureTime frame
Post-standardized meal glucose exposure (AUC)0-120 minutes after meal

Secondary

MeasureTime frame
Insulin exposure (AUC)Various time frames over 720 minutes
Maximal insulin concentration0-720 minutes
Post breakfast and post-lunch glucose exposure (AUC)Various times frames over 720 minutes
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)0-720 minutes
Injection site toleration (VAS and severity scales)30 minutes post injection
Draize injection site erythema and edema scoring0-720 minutes
Post-breakfast and post-lunch maximal glucose concentrations0-720 minutes

Countries

United States

Outcome results

None listed

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