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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States
      • Profil Institute for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIOD-531 pre-meal; Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast	Drug: BIOD-531
Active Comparator: Humalog Mix 75/25 pre-meal; Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast	Drug: Humalog Mix 75/25
Active Comparator: Humulin R U-500; Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast	Drug: Humulin R U-500
Experimental: BIOD-531 post-meal; Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast	Drug: BIOD-531

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-standardized meal glucose exposure (AUC)	0-120 minutes after meal

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biodel

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 8, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: January 15, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 3-152