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Search / Trial NCT02324309

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

Launched by BIODEL · Dec 19, 2014

Trial Information

Current as of June 18, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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

About Biodel

Biodel is a biopharmaceutical company focused on developing innovative therapies for diabetes and other metabolic disorders. With a commitment to advancing patient care, Biodel harnesses cutting-edge science and technology to create novel insulin formulations and delivery systems that enhance the efficacy and safety of diabetes management. The company is dedicated to conducting rigorous clinical trials to evaluate the effectiveness of its products, ensuring that they meet the highest standards of quality and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Biodel aims to improve the lives of individuals living with diabetes and contribute to the ongoing evolution of metabolic disease treatment.

Locations

Chula Vista, California, United States

Patients applied

0 patients applied

Trial Officials

Laurie Han-Conrad, MD

Principal Investigator

Profil Institute for Clinical Research, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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