Overview

This trial is active, not recruiting.

Condition type 2 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 July 2014
Trial size 12 participants
Trial identifier NCT02212951, 3-152

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.

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 injection of 0.6 U/kg immediately before the start of the standardized breakfast
biod-531
(Active Comparator)
Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
humalog mix 75/25
(Active Comparator)
Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast
humulin r u-500
(Experimental)
Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast
biod-531

Primary Outcomes

Measure
Post-standardized meal glucose exposure (AUC)
time frame: 0-120 minutes after meal

Secondary Outcomes

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

Eligibility Criteria

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

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

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 Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Biodel.