Diabetes, obesity & metabolism
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Diabetes Obes Metab · Jun 2020
Randomized Controlled TrialEfficacy and tolerability of tirzepatide, a dual glucose-dependent insulinotropic peptide and glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes: A 12-week, randomized, double-blind, placebo-controlled study to evaluate different dose-escalation regimens.
To assess the efficacy and tolerability of tirzepatide treatment using three different dose-escalation regimens in patients with type 2 diabetes. ⋯ Tirzepatide treatment for 12 weeks resulted in clinically significant reductions in HbA1c. This suggests that lower starting doses and smaller dose increments are associated with a more favourable side effect profile.
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Diabetes Obes Metab · Apr 2020
ReviewTransparency in real-world evidence (RWE) studies to build confidence for decision-making: Reporting RWE research in diabetes.
Transparency of real-world evidence (RWE) studies is critical to understanding how findings of a specific study were derived and is a necessary foundation to assessing validity and determination of whether decisions should be informed by the findings. In the present paper, we lay out strategies to improve clarity in the reporting of comparative effectiveness studies using real-world data that were generated by the routine operation of a healthcare system. This may include claims data, electronic health records, wearable devices, patient-reported outcomes or patient registries. ⋯ We highlight study elements that should be reported to provide the clarity necessary to make a study reproducible. Finally, we suggest registering study protocols to increase process transparency. With these tools the readership of diabetes RWE studies will be able to more efficiently understand each study and be more able to assess a study's validity with reasonably high confidence before making decisions based on its findings.
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Diabetes Obes Metab · Jan 2020
ReviewEffects of sodium-glucose cotransporter-2 inhibitors on the cardiovascular and renal complications of type 2 diabetes.
Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) have been shown to mitigate the risks of cardiovascular (CV) and renal complications in patients with type 2 diabetes (T2D) and CV risk factors or CV disease (CVD). In CV outcomes trials (CVOTs) of patients with T2D and established CVD or multiple CV risk factors, empagliflozin and canagliflozin were associated with significant reductions in the risks of major adverse CV events (MACE), hospitalization for heart failure (HF) and kidney disease progression. ⋯ The observed improvements in CV and renal outcomes with SGLT-2is in CVOTs suggest a class effect in this patient population and have influenced treatment guidelines for the way add-on therapy to metformin is initiated in patients with T2D and high CV risk. The overall cardioprotective and renoprotective effects of SGLT-2is in patients with T2D and high CV risk are most likely attributable to multiple mechanisms, including cardiac, haemodynamic, metabolic, anti-inflammatory and renal effects.
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Diabetes Obes Metab · Dec 2019
Observational StudyPredicting short- and long-term glycated haemoglobin response after insulin initiation in patients with type 2 diabetes mellitus using machine-learning algorithms.
To assess the potential of supervised machine-learning techniques to identify clinical variables for predicting short-term and long-term glycated haemoglobin (HbA1c) response after insulin treatment initiation in patients with type 2 diabetes mellitus (T2DM). ⋯ Machine-learning algorithm performed well in the prediction of an individual's short-term and long-term HbA1c response using baseline clinical variables.
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Diabetes Obes Metab · Oct 2019
Review Meta AnalysisSodium-glucose co-transporter inhibitors, their role in type 1 diabetes treatment and a risk mitigation strategy for preventing diabetic ketoacidosis: The STOP DKA Protocol.
Recent phase 3 clinical trials have evaluated the impact of adding sodium-glucose co-transporter (SGLT) inhibitors to the type 1 diabetes armamentarium. These trials studied SGLT2 inhibitors (dapagliflozin and empagliflozin) and a dual SGLT1 and SGLT2 inhibitor (sotagliflozin), and demonstrated that these oral non-insulin antihyperglycaemic medications are able not only to improve glycaemic control, but also to reduce body weight and extend time in range without increasing rates of hypoglycaemia in type 1 diabetes. Diabetic ketoacidosis (DKA) is a feature of type 1 diabetes and the risk is increased when SGLT inhibitors are used in type 1 diabetes. To minimize the risk of DKA and still gain the multiple benefits, we developed the "STOP DKA Protocol ", an easily accessible and practical tool, that provides a risk mitigation strategy for reducing DKA in patients with type 1 diabetes being treated with SGLT inhibitors.