Metabolic Responses of Dapagliflozin vs Sitagliptin in T2DM Patients Inadequately Controlled With Insulin Therapy

Launched by THE UNIVERSITY OF HONG KONG · May 20, 2019

Keywords

ClinConnect Summary

Sodium glucose co-transporter 2 (SGLT2) inhibitors introduce a novel approach of glycaemic control in type 2 diabetes (T2DM). Inhibition of SGLT2 causes glycosuria and lowers blood glucose levels regardless of insulin sensitivity and beta cell function. It has recently been shown that SGLT2 inhibition is efficacious and safe not only in diabetic patients with normal renal function but also in patients with chronic kidney disease stage 3a \[estimated glomerular filtration rate (eGFR) 45-59 mL/min/1.73m2\]. While the clinical efficacy has been well proven by various randomized controlled tria...

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Eligibility criteria

• Inclusion Criteria:
• • Chinese
• • Aged 21 to 75 both inclusive
• • Type 2 diabetes on single or two doses of insulin therapy with or without metformin, which include intermediate acting human insulin, premixed human insulin or insulin analogues
• • On stable insulin doses, as defined by less than 10% changes in total daily insulin dose within 3 months prior to randomization
• • Suboptimal glycaemic control with baseline HbA1c ≥8.0% and ≤10.5%, taken within 2 months prior to randomization
• • Body mass index between 21 and 40 kg/m2
• Exclusion Criteria:
• • Type 1 diabetes mellitus
• • History of ketoacidosis
• • Concurrent use of sulphonylurea or glucagon like peptide-1 receptor (GLP1) agonists
• • Prior use of SGLT2 inhibitors, DPP4-inhibitors or GLP1 agonists within 3 months of randomization
• • History of intolerance to SGLT2 inhibitors or DPP4-inhibitors
• • Concurrent use of loop diuretics
• • eGFR \<45 ml/min/1.73m2 within 3 months prior to randomization
• • History of acute or chronic pancreatitis
• • History of benign or malignant pancreatic tumours
• • History of bladder cancer
• • Alcohol or drug abuse
• • Pregnant or nursing women
• • Women at childbearing age not using and refused to start chemical or mechanical contraception after randomization
• • Severe liver disease with elevated plasma alanine aminotransferase (ALT) of more than five times the upper limit of normal, taken within 3 months prior to randomization
• • Active or history of malignancy within 5 years prior to randomization
• • Hospitalization for acute illness within 3 months prior to randomization
• • Severe mental disorder
• • Unable to understand written patient information and to give informed consent
• • Ongoing participation in other clinical intervention trials
• • Other unspecified concomitant conditions that deemed unsuitable for study participation upon professional judgments by principal investigators