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

Phase 1

Completed

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

• Registration Number: NCT02324309
• Lead Sponsor: Biodel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-11
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-24
• 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

• 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIOD-531 pre-meal	BIOD-531	Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
Humalog Mix 75/25 pre-meal	Humalog Mix 75/25	Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
Humulin R U-500 pre-meal	Humulin R U-500	Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner.
BIOD-531 post-meal	BIOD-531	Subcutaneous injections of 1.2 U/kg 20 minutes after the start of a standardized breakfast and 0.8 U/kg 20 minutes after the start of a standardized dinner.

Primary Outcome Measures

Name	Time	Method
Post-breakfast glucose exposure (AUC)	0-330 minutes

Secondary Outcome Measures

Name	Time	Method
Insulin exposure (AUC)	0-1440 minutes
Maximal insulin concentration	0-330 and 660-1020 minutes
Post-lunch and post-dinner glucose exposures (AUC)	330-660 and 660-1020 minutes
Injection site toleration (VAS and severity scales)	30 and 690 minutes
Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)	0-330 and 660-1020 minutes

Trial Locations

Locations (1)

Profil Institute for Clinical Research, Inc. (PICR); 🇺🇸 Chula Vista, California, United States