A clinical trial on a new diabetic drug at UCSF sheds light on the potential success of a new drug.
The University of California in San Francisco has completed a phase 2 clinical trial of a new drug called teplizumab. It is designed to block the advance of type 1 diabetes. It is shown success in about half of the patients who participated in the study.
Those suffering from type 1 diabetes are left with life-long complications effecting blood sugar levels, diet and metabolism. The slow onset of type 1 diabetes means the degeneration of the pancreas to accurately detect blood sugar levels and release the hormone insulin as needed. In this study, the drug teplizumab was administered regularly over the course of two years to maintain the little control they still had of blood sugar levels.
It was successful in about half of the participatns. All of the participants in the study were at similar stages of type 1 diabetes, where they still had partial functioning, and needed just moderate insulin injections.
The findings of the study will soon be published in the print version of the Journal, Diabetes. Co-leader of the research team said, "the benefits of treatment among the patients who still had moderately healthy insulin production suggests that the sooner we can detect the pre-diabetes condition and get this kind of drug onboard, the more people we can protect from the progressive damage caused by an autoimmune attack".
There were 52 participants, most of whom were 14 years or younger. They had all been diagnosed with new onset type 1 diabetes within 8 weeks of beginning the trial. They were treated with teplizumab for 2 weeks at onset of the trial, and then again 1 year later. Their results were compared to an untreated group. However, the participants still received regular insulin treatment, and thus the researchers were not measuring insulin production, but their levels of blood C-peptide, another molecule produced in the pancreas.
This study has many implications for the way that future sufferers of diabetes will be treated. Further investigation is needed to determine side effects and overall success with a larger test group.
K. C. Herold, S. E. Gitelman, M. R. Ehlers, P. A. Gottlieb, C. J. Greenbaum, W. Hagopian, K. D. Boyle, L. Keyes-Elstein, S. Aggarwal, D. Phippard, P. H. Sayre, J. McNamara, J. A. Bluestone. Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: Metabolic and immunologic features at baseline identify a subgroup of responders. Diabetes, 2013.