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OpenTrials
Completed

NCT Number: NCT02212951

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 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

Chula Vista, California, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BIOD-531

Drug

Humalog Mix 75/25

Drug

Humulin R U-500

Drug

Primary outcomes

  1. Post-standardized meal glucose exposure (AUC)

    Time frame: 0-120 minutes after meal

Secondary outcomes

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

    Time frame: 0-720 minutes

  2. Insulin exposure (AUC)

    Time frame: Various time frames over 720 minutes

  3. Maximal insulin concentration

    Time frame: 0-720 minutes

  4. Post breakfast and post-lunch glucose exposure (AUC)

    Time frame: Various times frames over 720 minutes

  5. Post-breakfast and post-lunch maximal glucose concentrations

    Time frame: 0-720 minutes

  6. Injection site toleration (VAS and severity scales)

    Time frame: 30 minutes post injection

  7. Draize injection site erythema and edema scoring

    Time frame: 0-720 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 Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day

Important dates

Study start
2014
Primary completion
2014
First posted
Aug 11, 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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