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

NCT02324309 | Completed Phase 1

• 1 other identifier: 3-151
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Post-breakfast glucose exposure (AUC)

  0-330 minutes

Secondary Outcomes (5)

• Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)

  0-330 and 660-1020 minutes

• 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

Study Arms (4)

BIOD-531 pre-meal

EXPERIMENTAL

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

Humalog Mix 75/25 pre-meal

ACTIVE COMPARATOR

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

Humulin R U-500 pre-meal

ACTIVE COMPARATOR

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

BIOD-531 post-meal

EXPERIMENTAL

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

Interventions

BIOD-531 DRUG

BIOD-531 pre-meal

Humalog Mix 75/25 DRUG

Humalog Mix 75/25 pre-meal

Humulin R U-500 DRUG

Humulin R U-500 pre-meal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Biodel: lead

Study Sites (1)

Profil Institute for Clinical Research, Inc. (PICR)

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Laurie Han-Conrad, MD

  Profil Institute for Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 24, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Last Updated: February 8, 2016

Record last verified: 2016-01

Locations

US (1)