StUdies of empaGliflozin and its cArdiovascular, Renal and metabolic effects in patients with Diabetes Mellitus (or prediabetes) and Heart Failure (SUGAR-DM-HF) - SUGAR-DM-HF

HS Greater Glasgow and Clyde0 sites100 target enrollmentMay 9, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic heart failure with left ventricular systolic dysfunction
Sponsor: HS Greater Glasgow and Clyde
Enrollment: 100
Status: Active, Not Recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

May 9, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

HS Greater Glasgow and Clyde

•Written informed consent
•Male or female, aged \=18 years age
•Type 2 DM (diet\-controlled or on stable treatment) or prediabetes
•o Stable treatment defined as no change in oral therapy agents or doses for diabetes mellitus and (where applicable) \<10% change in average total daily insulin dose over last 6 weeks
•o HbA1c \=97 mmol/mol (11%) (routine available data from medical records, recorded in the last year)
•o Prediabetes defined as HbA1c 39\-47 mmol/mol (5\.7\-6\.4%) at the time of screening (specifically for the prediabetes group, HbA1c will be repeated at the time of screening if there are no recent results within the last 3 months, in order to confirm the diagnosis of prediabetes)
•Heart failure (as defined by presence of typical signs and symptoms of heart failure with documented reduced ejection fraction (ref SIGN and ESC guidelines)):
•o NYHA class II\-IV
•o LVEF \=40%
•o On stable doses of ACEI, ARB or ARNI for 4 weeks prior to randomisation unless contraindicated or not tolerated. They should also be taking a beta\-blocker at a stable dose for 4 weeks unless contraindicated or not tolerated.

•Type 1 DM
•History of hospital admission with a diagnosis of diabetic ketoacidosis (DKA)
•Insulin use within 1 year of diagnosis of diabetes
•History of acute or chronic pancreatitis and on insulin treatment for diabetes or low residual c\-peptide (random non\-fasting level of \<0\.2 nmol/l)
•eGFR \<30 ml/min/1\.73m2 (derived using CKD EPI) at the time of randomisation (based on latest available result; kidney function tests will be repeated at the time of screening if there are no recent results: (a) within last 6 months in patients with eGFR \>60 ml/min/1\.73m2; (b) within last 3 months in patients with eGFR 45\-60 ml/min/1\.73m2; (c) within last 1 month in patients with eGFR 30\-44 ml/min/1\.73m2\)
•Persistent/permanent atrial fibrillation/flutter (conditions which significantly impede MRI image interpretability)
•Acute coronary syndrome, stroke or surgery within 1 month (small type 2 MI in the context of acute HF does not apply)
•BMI \>52kg/m2
•Liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal (ULN) at the time of screening (based on latest available result; liver function tests will be repeated at the time of screening if there are no recent (within last 6 months) results in patients without known liver disease)
•Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption