The University of Alabama at Birmingham (UAB) has launched a significant clinical trial investigating the comparative effectiveness of three distinct diabetes treatments in managing night-time blood sugar levels. This National Institutes of Health (NIH)-funded research aims to address a critical aspect of diabetes management that often challenges both patients and healthcare providers.
Study Design and Treatment Arms
The trial will evaluate three treatment approaches: the widely-prescribed oral medication Metformin, the long-acting Insulin Glargine, and the experimental drug Dorzagliatin, which has received FDA approval for research purposes. Participants will receive one of these treatments for up to 8 weeks, allowing researchers to assess their impact on nocturnal glucose control.
The comprehensive study protocol includes an initial screening process featuring blood draws, urine tests, and physical examinations. Participants will undergo 2-4 inpatient visits, including two overnight stays at the Clinical Research Unit located on the 15th floor of Jefferson Tower, with all study activities to be completed within a three-month timeframe.
Patient Eligibility and Compensation
The research team is specifically recruiting individuals diagnosed with type 2 diabetes who are not currently receiving any form of insulin therapy. This criterion ensures a clear assessment of treatment effects without the confounding influence of existing insulin regimens.
To facilitate participation and acknowledge the time commitment required, the study offers substantial compensation of up to $2,500 for participants who complete all study requirements. Additionally, all study-related procedures, tests, and medications are provided at no cost to the participants.
Clinical Significance
This research addresses an important aspect of diabetes management - the control of blood sugar levels during nighttime hours. Nocturnal glucose control presents unique challenges in diabetes treatment, and understanding the comparative effectiveness of different therapeutic approaches could lead to improved treatment strategies.
The inclusion of Dorzagliatin alongside established treatments like Metformin and Insulin Glargine represents an important step in evaluating newer therapeutic options against current standards of care. The findings from this study could potentially influence future treatment guidelines and provide healthcare providers with better evidence for tailoring diabetes management strategies to individual patient needs.
