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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324309
• Other study ID #: 3-151
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 17, 2014
• Last updated: January 15, 2016
• Start date: May 2014

Study information

• Verified date: January 2016
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• BIOD-531

• Humalog Mix 75/25

• Humulin R U-500

• BIOD-531

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research, Inc. (PICR)	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-breakfast glucose exposure (AUC)		0-330 minutes	No
Secondary	Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)		0-330 and 660-1020 minutes	No
Secondary	Insulin exposure (AUC)		0-1440 minutes	No
Secondary	Maximal insulin concentration		0-330 and 660-1020 minutes	No
Secondary	Post-lunch and post-dinner glucose exposures (AUC)		330-660 and 660-1020 minutes	No
Secondary	Injection site toleration (VAS and severity scales)		30 and 690 minutes	Yes