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

Type 2 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 Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212951
• Other study ID #: 3-152
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 7, 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 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.

Recruitment information / eligibility

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

Eligibility

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

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
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• BIOD-531

• Humalog Mix 75/25

• Humulin R U-500

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research	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-standardized meal glucose exposure (AUC)		0-120 minutes after meal	No
Secondary	Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)		0-720 minutes	No
Secondary	Insulin exposure (AUC)		Various time frames over 720 minutes	No
Secondary	Maximal insulin concentration		0-720 minutes	No
Secondary	Post breakfast and post-lunch glucose exposure (AUC)		Various times frames over 720 minutes	No
Secondary	Post-breakfast and post-lunch maximal glucose concentrations		0-720 minutes	No
Secondary	Injection site toleration (VAS and severity scales)		30 minutes post injection	Yes
Secondary	Draize injection site erythema and edema scoring		0-720 minutes	Yes