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

• Sponsor: Biodel (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02324309
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: BIOD-531; Drug: Humalog Mix 75/25; Drug: Humulin R U-500; Drug: BIOD-531	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BIOD-531 pre-meal 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.	Drug: BIOD-531
Active Comparator: Humalog Mix 75/25 pre-meal 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.	Drug: Humalog Mix 75/25
Active Comparator: Humulin R U-500 pre-meal 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.	Drug: Humulin R U-500
Experimental: BIOD-531 post-meal 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.	Drug: BIOD-531

Outcome Measures

Primary Outcome Measures

1. Post-breakfast glucose exposure (AUC) [0-330 minutes]

Secondary Outcome Measures

1. Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations) [0-330 and 660-1020 minutes]

2. Insulin exposure (AUC) [0-1440 minutes]

3. Maximal insulin concentration [0-330 and 660-1020 minutes]

4. Post-lunch and post-dinner glucose exposures (AUC) [330-660 and 660-1020 minutes]

5. Injection site toleration (VAS and severity scales) [30 and 690 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil Institute for Clinical Research, Inc. (PICR)	Chula Vista	California	United States	91911

Sponsors and Collaborators

• Biodel

Investigators

• Principal Investigator: Laurie Han-Conrad, MD, Profil Institute for Clinical Research, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biodel
• ClinicalTrials.gov Identifier: NCT02324309
• Other Study ID Numbers: 3-151
• First Posted: Dec 24, 2014
• Last Update Posted: Feb 8, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Insulin Lispro

Study Results

No Results Posted as of Feb 8, 2016