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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: BIOD-531; Drug: Humulin R U-500; Drug: Humalog Mix 75/25

• Registration Number: NCT02212951
• Lead Sponsor: Biodel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-07
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-11
• Status Verified: 2016-01
• Disposition First Submitted: 2016-01-15
• Disposition First Submitted QC: 2016-01-15
• Last Update Submitted: 2016-01-15
• Disposition First Posted: 2016-02-08
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIOD-531 post-meal	BIOD-531	Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast
Humulin R U-500	Humulin R U-500	Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast
Humalog Mix 75/25 pre-meal	Humalog Mix 75/25	Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast
BIOD-531 pre-meal	BIOD-531	Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast

Primary Outcome Measures

Name	Time	Method
Post-standardized meal glucose exposure (AUC)	0-120 minutes after meal

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Profil Institute for Clinical Research; 🇺🇸 Chula Vista, California, United States