Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments biod-531, humalog mix 75/25, humulin r u-500
Phase phase 1/phase 2
Sponsor Biodel
Start date May 2014
End date November 2014
Trial size 12 participants
Trial identifier NCT02324309, 3-151

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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.
biod-531
(Active Comparator)
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.
humalog mix 75/25
(Active Comparator)
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.
humulin r u-500
(Experimental)
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.
biod-531

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title 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
Principal investigator Laurie Han-Conrad, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Biodel.