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OpenTrials
Completed

NCT Number: NCT02324309

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Profil Institute for Clinical Research, Inc. (PICR)

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIOD-531

Drug

Humalog Mix 75/25

Drug

Humulin R U-500

Drug

Primary outcomes

  1. Post-breakfast glucose exposure (AUC)

    Time frame: 0-330 minutes

Secondary outcomes

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

    Time frame: 0-330 and 660-1020 minutes

  2. Insulin exposure (AUC)

    Time frame: 0-1440 minutes

  3. Maximal insulin concentration

    Time frame: 0-330 and 660-1020 minutes

  4. Post-lunch and post-dinner glucose exposures (AUC)

    Time frame: 330-660 and 660-1020 minutes

  5. Injection site toleration (VAS and severity scales)

    Time frame: 30 and 690 minutes

Sponsors and collaborators

Lead sponsor

Biodel

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
First posted
Dec 24, 2014
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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