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

• Sponsor: Biodel (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02212951
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: BIOD-531; Drug: Humalog Mix 75/25; Drug: Humulin R U-500	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 Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Post-standardized meal glucose exposure (AUC) [0-120 minutes after meal]

Secondary Outcome Measures

1. Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations) [0-720 minutes]

2. Insulin exposure (AUC) [Various time frames over 720 minutes]

3. Maximal insulin concentration [0-720 minutes]

4. Post breakfast and post-lunch glucose exposure (AUC) [Various times frames over 720 minutes]

5. Post-breakfast and post-lunch maximal glucose concentrations [0-720 minutes]

6. Injection site toleration (VAS and severity scales) [30 minutes post injection]

7. Draize injection site erythema and edema scoring [0-720 minutes]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil Institute for Clinical Research	Chula Vista	California	United States

Sponsors and Collaborators

• Biodel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biodel
• ClinicalTrials.gov Identifier: NCT02212951
• Other Study ID Numbers: 3-152
• First Posted: Aug 11, 2014
• Last Update Posted: Feb 8, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Lispro

Study Results

No Results Posted as of Feb 8, 2016