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 May 27, 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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chula Vista, California, United States
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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