Metabolic effects of an SGLT2 inhibitor (dapagliflozin) during a period of acute insulin withdrawal and development of ketoacidosis in people with type 1 diabetes

niversity of Leicester0 sites12 target enrollmentJanuary 2, 2020

Overview

2020 results in https://doi.org/10.2337/dc19-2579 (added 07/08/2020)

Registry

who.int

Start Date

January 2, 2020

End Date

August 1, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leicester

•1\. Able in the opinion of the investigator, and willing to give informed consent obtained before any study\-related activities
•2\. Type 1 diabetes or type 3c (chronic pancreatitis or undergone pancreatic surgery) according to clinical judgment
•3\. Duration of type 1 or type 3c diabetes (chronic pancreatitis or undergone pancreatic surgery) greater than 12 months
•4\. Current treatment basal bolus insulin regime or insulin pump therapy
•5\. Aged 18 – 65 years
•6\. BMI of less than 35
•7\. HbA1c of greater or equal to 6\.5% and less than 9%
•8\. Able and willing to complete the study
•9\. Patients who are or who have previously been involved in research are eligible provided they have not received an investigational drug within one month of entry into the study

•1\. Cannot adequately understand verbal and / or written explanations given in English
•2\. LADA –latent autoimmune diabetes in adults due to differing nature of the illness/Type 1
•3\. Confirmed excessive and compulsive drinking of alcohol i.e. alcohol abuse as determined from GP medical notes by the Fast Alcohol Screening Test (FAST) or history of previous alcohol abuse
•4\. Restricted food intake (e.g. on VLC diets) \- as this depletes the person of calories and may affect your data. Consider excluding Individuals on a severe calorie restricted diet \<800cals/day. Determined by history
•5\. Diagnosis of osteoporosis confirmed by DEXA scan
•6\. Proliferative retinopathy that has required acute treatment within last three months
•7\. Moderate to severe renal impairment (creatinine clearance \[CrCl] \< 60 ml/min or estimated glomerular filtration rate \[eGFR] \< 60 ml/min/1\.73 m²
•8\. History of unstable or rapidly progressing renal disease
•9\. Severe hepatic insufficiency / and or significant abnormal liver function defines as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and / or alanine aminotransferase (ALT) \> 3ULN
•10\. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody