A5036911910- Statistical Methods in Clinical Trials
- Statistical Methods and Inference
- Advanced Causal Inference Techniques
- Diabetes Management and Research
- Diabetes Treatment and Management
- Statistical Methods and Bayesian Inference
- Health Systems, Economic Evaluations, Quality of Life
- Pancreatic function and diabetes
- Bone health and osteoporosis research
- Diabetes and associated disorders
- Estrogen and related hormone effects
- Optimal Experimental Design Methods
- Metabolism, Diabetes, and Cancer
- Advanced Statistical Methods and Models
- Pharmaceutical Economics and Policy
- Bone health and treatments
- Computational Drug Discovery Methods
- Meta-analysis and systematic reviews
- Bone Metabolism and Diseases
- Endometriosis Research and Treatment
- Pharmaceutical studies and practices
- Menopause: Health Impacts and Treatments
- Cancer Risks and Factors
- Lipoproteins and Cardiovascular Health
- Bayesian Methods and Mixture Models
Eli Lilly (United States)
2016-2025
Zimmer Biomet (United States)
2019-2020
North American Menopause Society
2007
Weatherford College
2007
Virginia Commonwealth University Medical Center
2007
Rapid Medical Research
2007
Holmes Community College
2007
Iowa State University
2002
Abstract In the CORE breast cancer trial of 4011 women continuing from MORE, incidence nonvertebral fractures at 8 years was similar between placebo and raloxifene 60 mg/day. had limitations for assessing fracture risk. a subset 386 women, 7 treatment significantly increased lumbar spine femoral neck BMD compared baseline MORE. Introduction: The multicenter, double-blind Continuing Outcomes Relevant to Evista (CORE) assessed effects on 4 additional beyond 4-year Multiple Raloxifene...
We set out to study the relationship between different measures of glycemic variability and rate hypoglycemia in patients with type 2 diabetes.Data were pooled from three 24-week insulin trials including on twice-daily (BID) lispro mix 75/25 (75% protamine suspension, 25% lispro) (n=805), daily (QD) glargine (n=1,019), suspension (n=353) (QD or BID), detemir (n=166) all continuation prestudy oral antihyperglycemic medications. Glycemic derived seven-point self-monitored blood glucose...
OBJECTIVE To evaluate whether LY2605541 results in lower fasting blood glucose (FBG) versus insulin glargine (GL). RESEARCH DESIGN AND METHODS This 12-week, randomized, open-label, Phase 2 study enrolled patients with type diabetes (hemoglobin A1c [A1C] ≤ 10.5%), taking metformin and/or sulfonylurea GL or NPH once daily. Patients converted to morning administration during lead-in were randomized 2:1 from (n = 248) 39) 195) 95) daily the morning. RESULTS At 12 weeks, FBG (mean ± SE) was...
OBJECTIVE Study the effects of exenatide (EXE) plus rosiglitazone (ROSI) on β-cell function and insulin sensitivity using hyperglycemic euglycemic clamp techniques in participants with type 2 diabetes metformin. RESEARCH DESIGN AND METHODS In this 20-week, randomized, open-label, multicenter study, (mean age, 56 ± 10 years; weight, 93 16 kg; A1C, 7.8 0.7%) continued their metformin regimen received either EXE μg b.i.d. (n = 45), ROSI 4 mg or + 47). Seventy-three underwent procedures to...
Abstract Propensity scores have been used widely as a bias reduction method to estimate the treatment effect in nonrandomized studies. Since many covariates are generally included model for estimating propensity scores, proportion of subjects with at least one missing covariate could be large. While methods proposed score‐based estimation presence covariates, little has published comparing performance these methods. In this article we propose novel called multiple imputation missingness...
OBJECTIVE To compare effects of LY2605541 versus insulin glargine on daily mean blood glucose as part a basal-bolus regimen for type 1 diabetes. RESEARCH DESIGN AND METHODS In this randomized, Phase 2, open-label, 2 × crossover study, 137 patients received once-daily basal (LY2605541 or glargine) plus mealtime 8 weeks, followed by treatment weeks. Daily was obtained from 8-point self-monitored profiles. The noninferiority margin 10.8 mg/dL. RESULTS met and superiority criteria compared with...
In Brief Objective: To compare effects of 52 weeks' treatment with either raloxifene 60 mg/day alone (RLX) or in combination 17β-estradiol 1 (RLX + E) on vasomotor symptoms (n = 83) and endometrial safety 123) postmenopausal women who transitioned from estrogen-progestin therapy. Design: this randomized, double-blind clinical trial, the frequency symptoms, hot flashes, night sweats was assessed for up to weeks. Endometrial thickness by transvaginal ultrasonography at baseline 12 An exit...
In this paper we study sample size calculation methods for the asymptotic Wilcoxon-Mann-Whitney test data with or without ties. The existing are applicable either to ties but not both cases. While developed perform well, have limitations in that they proportional odds alternatives computational difficulties. We propose a new method which has closed-form formula and therefore is very easy calculate. addition, can be applied Simulations demonstrated performs well as corresponding actual powers...
To compare the efficacy and safety of basal insulin peglispro (BIL), which has a flat pharmacokinetic pharmacodynamic profile long duration action, with glargine (GL) in patients type 1 diabetes.In this phase III, 52-week, blinded study, we randomized 1114 adults diabetes 3 : 2 distribution to receive either BIL (n = 664) or GL 450) at bedtime, preprandial lispro, using intensive management. The primary objective was glycated haemoglobin (HbA1c) groups 52 weeks, non-inferiority margin...
The ICH E9(R1) addendum (2019) proposed principal stratification (PS) as one of five strategies for dealing with intercurrent events. Therefore, understanding the strengths, limitations, and assumptions PS is important broad community clinical trialists. Many approaches have been developed under general framework in different areas research, including experimental observational studies. These diverse applications utilized a set tools assumptions. Thus, need exists to present these unifying...
Generalized linear models are commonly used to analyze categorical data such as binary, count, and ordinal outcomes. Adjusting for important prognostic factors or baseline covariates in generalized may improve the estimation efficiency. The model-based mean a treatment group produced by most software packages estimates response at covariate, not this studied population. Although is an issue models, could be seriously biased true means. We propose new method estimate consistently with...
The primary objective was to demonstrate that basal insulin peglispro (BIL) non-inferior compared with glargine (GL) for haemoglobin A1c (HbA1c) at 26 weeks a non-inferiority margin of 0.4%.IMAGINE 1 Phase 3, open-label, parallel-arm study conducted in nine countries. Adults type diabetes (n = 455) were randomized (2:1) bedtime BIL or GL combination prandial lispro 78 weeks, endpoint weeks. An electronic diary facilitated data capture and dosing calculations intensive management.At mean...
To use continuous glucose monitoring (CGM) to evaluate the impact of novel, long-acting basal insulin analog LY2605541 on hypoglycemia and glycemic variability in patients with type 2 diabetes.Hypoglycemia were assessed CGM interstitial (IG) a subset diabetes from phase II, randomized, open-label, parallel study (n = 51) or glargine (GL) 25). was conducted 3 consecutive days (72-84 h) during week before 0, 6, 12 visits.Measured by for prior 12-week visit, fewer LY2605541-treated experienced...
Yongming Qua, Haoda Fua, Junxiang Luob & Stephen J. Rubergc*a Eli Lilly and Company, Indianapolis, IN; b Sanofi, Bridgewater, NJ; c Analytix Thinking, LCC, IN
Abstract Aims/hypothesis Whether hypoglycaemia increases the risk of other adverse outcomes in diabetes remains controversial, especially for episodes not requiring assistance from another person. An objective Hypoglycaemia REdefining SOLutions better liVEs (Hypo-RESOLVE) project was to create and use a dataset pooled clinical trials people with type 1 or 2 examine association exposure all across range severity incident event outcomes: death, CVD, neuropathy, kidney disease, retinal...
Background and objective: In two previously reported multi-center, randomized, open-label, comparator (insulin) controlled trials in patients with type 2 diabetes sub-optimally metformin a sulfonylurea, treatment exenatide insulin analogue therapy produced similar reductions glycosylated hemoglobin A1c (A1C). However, was associated reduction body weight while gain. This analysis further characterizes the relative impact of commonly employed analogues versus on change over 6-month...
Summary Intercurrent events (ICEs) and missing values are inevitable in clinical trials of any size duration, making it difficult to assess the treatment effect for all patients randomized trials. Defining appropriate estimand that is relevant research question first step analyzing data. The tripartite estimands, which evaluate differences proportion with ICEs due adverse events, lack efficacy, primary efficacy outcome those who can adhere study under causal inference framework, interest...
The current COVID-19 pandemic poses numerous challenges for ongoing clinical trials and provides a stress-testing environment the existing principles practice of estimands in trials. may increase rate intercurrent events (ICEs) missing values, spurring great deal discussion on amending protocols statistical analysis plans to address these issues. In this article we revisit recent research handling especially ICH E9 (R1) Estimands Sensitivity Analysis Clinical Trials. Based an in-depth...
Objective: Raloxifene treatment (60 mg/day) significantly decreases the risk of new clinical vertebral fractures by 68% at 1 year compared with placebo. The objective present analysis is to evaluate effects raloxifene on incidence 3 and 6 months after initiation treatment.Research design methods: A double-blind, randomized, placebo-controlled, 4‐year Multiple Outcomes Evaluation (MORE) trial was conducted in 180 study centers. Postmenopausal women osteoporosis (N = 7705) were randomized...