Treatment Benefit of Sotagliflozin in Patients With Type 1 DM
Research type
Research Study
Full title
Treatment Benefit of Sotagliflozin in Patients With Type 1 Diabetes Mellitus: Interviews With a Subset of Patients Exiting LX4211.309 and LX4211.310
IRAS ID
238720
Contact name
Simon Heller
Contact email
Sponsor organisation
Lexicon Pharmaceuticals
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
Type 1 Diabetes Mellitus, also known as T1DM, is an auto immune disease in which the immune system has attacked insulin producing cells in the pancreas, causing the body to no longer be able to produce insulin. T1DM causes blood glucose levels to rise unless counteracted by insulin injections by the patient - because dosages are subjective this means that incidents of hyperglycaemia (high blood glucose) and hypoglycaemia (low blood glucose) are likely. Hyperglycaemia can cause long term complications such as: Neuropathy (nerve damage), Diabetic Nephropathy (kidney damage), and Retinopathy (damage to blood vessels in the retina, potentially causing blindness).
Recent clinical research has shown taking a new medicine called Sotagliflozin can reduce peaks in postprandial (post meal) glucose without inducing hypoglycaemia, thus allowing greater blood glucose control than using insulin alone.
Other potential treatment benefits, such as increased treatment satisfaction and reduced stress and worry about hypoglycemia, were also reported. Furthermore, patients reported satisfaction with weight loss. Anecdotal reports suggest that patients expressed interest in continuing the study medication after completing the clinical trial.
This research will conduct in-depth interviews with a subset of patients who exited the recent studies with Sotagliflozin. It is anticipated that the collection of data during the patient interviews will provide greater detail surrounding the overall results of these clinical trials and provide greater perspective surrounding patient experiences before, during, and after treatment.REC name
Wales REC 6
REC reference
18/WA/0068
Date of REC Opinion
15 Feb 2018
REC opinion
Favourable Opinion