Gregory T. Golm
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View article: Vericiguat for patients with heart failure and reduced ejection fraction across the risk spectrum: an individual participant data analysis of the VICTORIA and VICTOR trials
Vericiguat for patients with heart failure and reduced ejection fraction across the risk spectrum: an individual participant data analysis of the VICTORIA and VICTOR trials Open
Merck Sharp & Dohme (a subsidiary of Merck) and Bayer.
View article: Prior Effective Sample Size When Borrowing on the Treatment Effect Scale
Prior Effective Sample Size When Borrowing on the Treatment Effect Scale Open
With the robust uptick in the applications of Bayesian external data borrowing, eliciting a prior distribution with the proper amount of information becomes increasingly critical. The prior effective sample size (ESS) is an intuitive and e…
View article: Robust analyzes for longitudinal clinical trials with missing and non-normal continuous outcomes
Robust analyzes for longitudinal clinical trials with missing and non-normal continuous outcomes Open
Missing data is unavoidable in longitudinal clinical trials, and outcomes are not always normally distributed. In the presence of outliers or heavy-tailed distributions, the conventional multiple imputation with the mixed model with repeat…
View article: Robust analyses for longitudinal clinical trials with missing and non-normal continuous outcomes
Robust analyses for longitudinal clinical trials with missing and non-normal continuous outcomes Open
Missing data is unavoidable in longitudinal clinical trials, and outcomes are not always normally distributed. In the presence of outliers or heavy-tailed distributions, the conventional multiple imputation with the mixed model with repeat…
View article: Efficient Multiple Imputation for Sensitivity Analysis of Recurrent Events Data with Informative Censoring
Efficient Multiple Imputation for Sensitivity Analysis of Recurrent Events Data with Informative Censoring Open
Missing data are commonly encountered in clinical trials due to dropout or nonadherence to study procedures. In trials in which recurrent events are of interest, the observed count can be an undercount of the events if a patient drops out …
View article: Missing Data Imputation With Baseline Information in Longitudinal Clinical Trials
Missing Data Imputation With Baseline Information in Longitudinal Clinical Trials Open
In longitudinal clinical trials, missing data are inevitable despite every effort made to retain patients in the trial. Missing data cause difficulty in the estimation and interpretation of the treatment effect. When the primary objective …
View article: Efficient Multiple Imputation for Sensitivity Analysis of Recurrent Events Data with Informative Censoring
Efficient Multiple Imputation for Sensitivity Analysis of Recurrent Events Data with Informative Censoring Open
Missing data are commonly encountered in clinical trials due to dropout or nonadherence to study procedures. In trials in which recurrent events are of interest, the observed count can be an undercount of the events if a patient drops out …
View article: Missing Data Imputation with Baseline Information in Longitudinal Clinical Trials
Missing Data Imputation with Baseline Information in Longitudinal Clinical Trials Open
In longitudinal clinical trials, missing data is inevitable despite every effort made to retain patients in the trial. Missing data causes difficulty in the estimation and interpretation of the treatment effect. When the primary objective …
View article: Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin
Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin Open
Objective: To assess the safety and efficacy of ertugliflozin over 104 weeks in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin. Methods: In this double-blind, multicenter, randomized, phase III study (VE…
View article: Double‐blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase‐4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT‐I Study
Double‐blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase‐4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT‐I Study Open
Aims To compare the effects of continuing versus discontinuing sitagliptin when initiating and intensively titrating insulin glargine. Materials and methods Eligible patients had inadequately controlled type 2 diabetes on metformin (≥1500 …
View article: Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV)
Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV) Open
The results from the VERTIS-CV trial will define the CV and renal safety and efficacy of ertugliflozin in patients with T2DM and ASCVD.
View article: Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study
Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study Open
Clinicaltrials.gov NCT02226003.
View article: Ertugliflozin Compared with Glimepiride in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin: The VERTIS SU Randomized Study
Ertugliflozin Compared with Glimepiride in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin: The VERTIS SU Randomized Study Open
Introduction This study assessed the safety and efficacy of ertugliflozin (an oral sodium-glucose cotransporter 2 inhibitor) vs. glimepiride in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin. Methods Thi…
View article: Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The <scp>VERTIS FACTORIAL</scp> randomized trial
Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The <span>VERTIS FACTORIAL</span> randomized trial Open
Aim To evaluate the efficacy and safety of ertugliflozin and sitagliptin co‐administration vs the individual agents in patients with type 2 diabetes who are inadequately controlled with metformin. Methods In this study ( Clinicaltrials.gov…
View article: Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: The <scp>VERTIS SITA2</scp> placebo‐controlled randomized study
Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: The <span>VERTIS SITA2</span> placebo‐controlled randomized study Open
Aims To assess ertugliflozin in patients with type 2 diabetes who are inadequately controlled by metformin and sitagliptin. Materials and Methods In this double‐blind randomized study ( Clinicaltrials.gov NCT02036515), patients (glycated h…
View article: Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co‐administered to Chinese patients with type 2 diabetes mellitus
Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co‐administered to Chinese patients with type 2 diabetes mellitus Open
Introduction The results of a clinical trial to evaluate the efficacy and safety of initial combination therapy with sitagliptin and metformin in Chinese patients with type 2 diabetes and inadequate glycemic control are reported here. Mate…