Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making. | Therapeutic Innovation and Regulatory Science | 2022 |
Role of dipeptidyl peptidase 4 inhibitors in the new era of antidiabetic treatment. | World Journal of Diabetes | 2022 |
Early Phase Metabolic Research with Reference to Special Populations | | 2019 |
Placebo Effects and Placebo Control in Clinical Trials | | 2016 |
Introduction | SpringerBriefs in Statistics | 2016 |
Influence of the Regulatory Environment on Attrition | | |
The Cardiovascular Benefits Associated with the Use of Sodium-Glucose Cotransporter 2 Inhibitors - Real-World Data | European Endocrinology | 2018 |
The Genesis of Cardiovascular Safety Regulatory Landscapes for New Antidiabetic Drugs for Type 2 Diabetes | | 2017 |
Synthetic long-acting insulin analogs for the management of type 1 diabetes: an update | Expert Opinion on Pharmacotherapy | 2021 |
Approvals of type 2 diabetes drugs tested in cardiovascular outcome trials: A tripartite comparison | British Journal of Clinical Pharmacology | 2021 |
FDA's New Guidance for Industry Addressing Evaluation of the Safety of New Drugs for Improving Glycemic Control: A Case Study in Regulatory Science | Therapeutic Innovation and Regulatory Science | 2021 |
Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors: Are They All the Same? A Narrative Review of Cardiovascular Outcome Trials | Diabetes Therapy | 2021 |
Cardiovascular and kidney outcomes of linagliptin treatment in older people with type 2 diabetes and established cardiovascular disease and/or kidney disease: A prespecified subgroup analysis of the randomized, placebo-controlled CARMELINA® trial | Diabetes, Obesity and Metabolism | 2020 |
Proceedings of the Guideline Workshop 2019 - Strategies for the optimization of guideline processes in diabetes, cardiovascular diseases and kidney diseases | Diabetes Research and Clinical Practice | 2020 |
Cardiovascular outcomes, heart failure and mortality in type 2 diabetic patients treated with glucagon-like peptide 1 receptor agonists (GLP-1 RAs): A systematic review and meta-analysis of observational cohort studies | International Journal of Clinical Practice | 2020 |
Assessing autonomic control of metabolic syndrome by principal component analysis: a data driven methodology | Health and Technology | 2020 |
Renal Outcomes in Type 2 Diabetes: A Review of Cardiovascular and Renal Outcome Trials | Diabetes Therapy | 2020 |
Incretins in obesity and diabetes | Annals of the New York Academy of Sciences | 2020 |
Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: Rationale, design and patient baseline characteristics for the PIONEER 6 trial | Diabetes, Obesity and Metabolism | 2019 |
Management of people with Type 2 diabetes shared between a specialized outpatient clinic and primary health care is noninferior to management in a specialized outpatient clinic: a randomized, noninferiority trial | Diabetic Medicine | 2019 |
Effect of Linagliptin vs Placebo on Major Cardiovascular Events in Adults With Type 2 Diabetes and High Cardiovascular and Renal Risk: The CARMELINA Randomized Clinical Trial | JAMA - Journal of the American Medical Association | 2019 |
Linagliptin Effects on Heart Failure and Related Outcomes in Individuals With Type 2 Diabetes Mellitus at High Cardiovascular and Renal Risk in CARMELINA | Circulation | 2019 |
Fixed-ratio combination of insulin degludec and liraglutide (IDegLira) improves cardiovascular risk markers in patients with type 2 diabetes uncontrolled on basal insulin | Diabetes, Obesity and Metabolism | 2019 |
Drug Development for Diabetes Mellitus: Beyond Hemoglobin A1c | | 2019 |
Translating the dose response into risk and benefit | British Journal of Clinical Pharmacology | 2019 |
Reduction of blood glucose and HbA1c levels by cyanidin 3,5-diglucoside in KKAy mice | Journal of Functional Foods | 2019 |
Glucose-lowering drugs and heart failure: implications of recent cardiovascular outcome trials in type 2 diabetes | Diabetes Research and Clinical Practice | 2019 |
Can hypoglycemic episodes in type 1 diabetics trigger cardiac arrhythmias? | Diabetes Research and Clinical Practice | 2019 |
Cardiovascular risks associated with dipeptidyl peptidase-4 inhibitors monotherapy compared with other antidiabetes drugs in the Japanese population: A nationwide cohort study | Pharmacoepidemiology and Drug Safety | 2019 |
Managing Cardiovascular Risk in Type 2 Diabetes: What Do the Cardiovascular Outcome Trials Mean for Australian Practice? | Diabetes Therapy | 2019 |
Cardiovascular protection in type 2 diabetes: Insights from recent outcome trials | Diabetes, Obesity and Metabolism | 2019 |
The European Medicines Agency's approval of new medicines for type 2 diabetes | Diabetes, Obesity and Metabolism | 2018 |
Diabetes, cardiovascular disease and the microcirculation | Cardiovascular Diabetology | 2018 |
Report from the 3rd Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes & Cardiovascular Disease (D&CVD) EASD Study Group | Cardiovascular Diabetology | 2018 |
European Medicines Agency: Approval of new glucose-lowering medicines for type 2 diabetes | Diabetes, Obesity and Metabolism | 2018 |
Precision medicine in diabetes and diabetic kidney disease: Regulatory considerations | Diabetes, Obesity and Metabolism | 2018 |
More cardiovascular outcomes trials in people with diabetes: time to change the NICE guidelines | Practical Diabetes | 2018 |
Similar Efficacy and Safety of Basaglar and Lantus in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study | Diabetes Therapy | 2018 |
Glucagon-like peptide 1 in health and disease | Nature Reviews Endocrinology | 2018 |
A Systematic Literature Review and Network Meta-Analysis Comparing Once-Weekly Semaglutide with Other GLP-1 Receptor Agonists in Patients with Type 2 Diabetes Previously Receiving Basal Insulin | Diabetes Therapy | 2018 |
Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk | Cardiovascular Diabetology | 2018 |
Effect of glucose-lowering therapies on heart failure | Nature Reviews Cardiology | 2018 |
Tracking the Sugar Rush: Incorporating Continuous Glucose Monitoring Into Multisite Early Clinical Research With Type 2 Diabetes Subjects | Clinical Pharmacology in Drug Development | 2018 |
A Systematic Literature Review and Network Meta-Analysis Comparing Once-Weekly Semaglutide with Other GLP-1 Receptor Agonists in Patients with Type 2 Diabetes Previously Receiving 1-2 Oral Anti-Diabetic Drugs | Diabetes Therapy | 2018 |
Why prescribe exercise as therapy in type 2 diabetes? We have a pill for that! | Diabetes/Metabolism Research and Reviews | 2018 |
Inconclusive effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes | Practical Diabetes | 2017 |
With regard to the paper by Zannad et al. entitled Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment versus risk aversion | European Heart Journal - Cardiovascular Pharmacotherapy | 2017 |
The Central Role of Cardiovascular Safety in Drug Development and Therapeutic Use | | 2017 |
Satisfying the Regulatory Requirements for New Antidiabetic Drugs for Type 2 Diabetes Most Expeditiously | | 2017 |
Clinical Outcomes of Patients with Diabetes Who Exhibit Upper-Quartile Insulin Antibody Responses After Treatment with LY2963016 or Lantus Insulin Glargine | Diabetes Therapy | 2017 |