The effect of SGLT2 inhibitors in people with type 2 diabetes

Phase 1

• Conditions: Type 2 diabetes.

• Registration Number: EUCTR2016-004878-17-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 18

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

•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] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2.
•History of unstable or rapidly progressing renal disease.
•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.
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified