Type 2 diabetes.
Conditions
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Able in the opinion of the investigator, and willing to give informed consent obtained before any study-related activities. • Diagnosis of type 2 diabetes greater than 12 months. • Single, dual or triple therapy glucose lowering agents comprising of sulphonylureas, biguanides and DDP-IV. • No previous exposure to SGLT2 inhibitors. • Aged 18 – 75 years. • BMI of less than 40. • HbA1c of greater or equal to 6.5% and less than 9% within 1 month of screening. • Able to comply with the study and the study procedures. • 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Participants over 75. • Participants under 18. • Participants who cannot adequately understand verbal and / or written explanations given in English. • Clinical suspicion of Hypoglycaemic unawareness. • LADA –latent autoimmune diabetes in adults due to differing nature of the illness/Type 1. • 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. • Has a history of chronic pancreatitis • Restricted food intake - Determined by history. • Diagnosis of osteoporosis confirmed by DEXA scan. • Participants on insulin, insulin analogs or GLP-1 in the preceding 6 months. • Proliferative retinopathy that has required acute treatment within last three months. • Moderate to severe renal impairment (creatinine clearance [CrCl] 3x upper limit of normal (ULN) and / or alanine aminotransferase (ALT) > 3ULN. • Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody. • Congestive heart failure defined as New York Heart Association (NYHA) class III and IV, unstable or acute congestive heart failure. • Uncontrolled cardiac arrhythmias. • Uncontrolled hypertension. (BP greater than 160/90). • Mental incapacity. • Pregnancy or breast feeding women. • Those of child-bearing potential not taking adequate contraception precautions. ?Adequate protection is defined as barrier protection, oral contraceptive pill or intrauterine device. • Volume depleted patients, patients at risk of volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status. • History of unstable angina. • Acute Coronary Syndrome (ACS) within 2 months prior to enrolment • Hospitalisation for unstable angina or acute myocardial infarction within 2 months prior to enrolment. • Acute Stroke or TIA within two months prior to enrolment. • Less than two months post coronary artery revascularisation. • History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalisation) within 1 month prior to the screening visit. • Known or suspected allergy to study products. • Known Lactose-intolerant. • Have severe and enduring mental health problems • Are not primarily responsible for their own care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Treatment with Dapagliflozin will result in a statistically significant difference in palmitate production when compared with placebo.; Primary end point(s): Primary endpoint outcome measure: Plasma palmitate production rate. ;Timepoint(s) of evaluation of this end point: 480 minutes; Secondary Objective: Treatment with Dapagliflozin will result in a statistically significant difference in glucose production, ketone body formation and flux when compared with placebo. Treatment with Dapagliflozin will result in a statistically significant difference action in the sympathetic nervous system and cardiac function when compared with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Metabolic assessment: 480 minutes. Exercise test. At end of individual exercise test. ; Secondary end point(s): Treatment with Dapagliflozin will result in a statistically significant difference in glucose production, ketone body formation and flux with Dapagliflozin when compared with placebo. Treatment with Dapagliflozin will result in a statistically significant difference action on the sympathetic nervous system and cardiac function with chronic administration of SGLT2 inhibitors in people with Type 2 diabetes. | — |
Countries
United Kingdom
Contacts
Public ContactRoselle Herring
Royal Surrey County Hospital
Outcome results
None listed