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Previous Studies

Studies:

1. Advanced Diabetes Treatment Centers. MAT Research, Winter Park, Fl. 2002-2008
2. Clinical Trials Management Research. 2008
3. INCB 13739-202 2ble blind, dose ranging, placebo controlled randomized study to evaluate the safety and efficacy of INCB013739 plus metformin compared to metformin alone on glycemic control in Type 2 DM. Incyte Corporation. 2008. Sub-Investigator
4. Takeda. SYR 322_303 Multicenter randomized, 2ble blind study to evaluate the efficacy and safety of alogliptin compared to glipizide in elderly subjects with Type 2 DM. 2008. Sub-Investigator
5. Phase III, 3 arm, randomized, 2ble blind, placebo controlled multicenter study to investigate the impact of Diamyd in the progression of DM in newly diagnosed patients with Type 1. 2008. Sub-investigator
6. Randomized, 2ble blind, 2-arm Parallel-group, 3 year, Multicenter Study to determine the Efficacy, safety, and tolerability of titrated doses of JNJ-28431754 versus titrated doses of glimepiride in the treatment of subjects with Type 2 DM not optimally controlled on Metformin. 2008. Sub-Investigator
7. Randomized, 2ble blind, Placebo controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 DM. 2008. Sub-Investigator
8. Glumetza Observational Study. Add-on to SU or metformin + SU combo therapy. Project # 11954. Roche protocol RO5073031. Completed 2008 Sub-Investigator
9. 6 month, multicenter, randomized, open label, parallel group study comparing the efficacy and safety of a new formulation of insulin glargine and Lantus both plus mealtime insulin in patients with type-2 diabetes with a 6 month safety extension period. Completed 2013. Principal Investigator
10. 6 month, multicenter, randomized, open-label, parallel-group study comparing the efficacy and safety of a new formulation of insulin glargine and Lantus both in combination with oral antihyperglycemic drugs in patients with type 2 diabetes mellitus with a 6 month safety extension period. Completed 2013. Principal Investigator.
11. An ACromegaly, open-label, multiCEnter, Safety monitoring program for treating patients with SOM233 (pasireotide) LAR who have need to receive medical therapy (ACCESS). Completed 2015. Principal Investigator.
12. A randomize, 30 week, active-controlled, open-label, 3-treatment arm, parallel-group multicenter study comparing the efficacy and safety of insulin Glargine/lixisenatide fixed ratio combination to insulin Glargine alone and to lixisenatide alone on top of metformin in patients with type 2 diabetes mellitus (T2DM). Completed 2014. Principal Investigator.
13. A randomized, 30-week, active-controlled, open-label, 2 treatmant-arm, parallel-group, multicenter study comparing the efficacy and safety of the insulin Glargine/lixisenatide fixed ratio combination to insulin Glargine with or without metformin in patients with T2DM. Completed 2014. Principal Investigator.
14. A randomized, open-label-2-arm parallel-group, multicenter, 26-week study assessing the safety and efficacy of HOE901-U300 versus Lantus in older patients with type 2 diabetes inadequately controlled on antidiabetic regimens either including insulin, or basal insulin as their only insulin. Completed 2016, Principal Investigator.
15. Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog in Adult Patients with Type 2 Diabetes Mellitus also using Insulin Glargine. Completed 2016, Principal Investigator.
16. A randomized, open-label, parallel group real world pragmatic trial to assess the clinical and health outcomes of Toujeo® compared to commercially available basal insulins for initiation of therapy in insulin naïve patients with uncontrolled type 2 diabetes mellitus. Completed 2018. Principal Investigator.
17. Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab versus Usual Care in Patients with Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk with Non-HDL-C Not Adequately Controlled with Maximally Tolerated Statin Therapy. Completed 2017. Principal Investigator.
18. A 24-week, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-Naive Patients with Type 2 Diabetes Mellitus not Adequately Controlled with Oral Antidiabetic Drug(s) ± GLP-1 receptor agonist” (“Protocol”). Completed 2017.. Principal Investigator.
19. A Randomized, Active-Controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients with Type 1 Diabetes Mellitus. Completed 2017. Principal Investigator.
20. Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, with a 6-month Safety Extension Period. Completed 2018. Principal Investigator.
21. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea alone or in combination with Metformin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or with Metformin Completed 2019 Principal Investigator.
22. A Randomized, Double-blind, Placebo- controlled, 3-arm, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Mellitus and Severe Renal Impairment who have Inadequate Glycemic Control. Completed 2019 Principal Investigator.
23. A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment who have Inadequate Completed 2019, Principal Investigator.
24. A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and
Safety of Sotagliflozin compared to Glimepiride or Placebo Added to Metformin in Patients with Type 2 Diabetes who have Inadequate Glycemic Control with
Metformin Monotherapy. Completed 2019 Principal Investigator.
25. A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess Safety, Tolerability, and Renal Effects of TMX-049 in Subjects with Type 2 Diabetes and Albuminuria. Completed 2019. Principal Investigator.
26. TRAVERSE Study. Testosterone Replacement Therapy for Assessment of long-term Vascular Events and Efficacy Response in Hypogonadal Men. Sponsor AbbVie. Aug 2018, ongoing. Principal Investigator.
27. A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP-4) With or Without Metformin. Completed 2019, Principal Investigator.
28. Phase3B/4 Randomized Safety Endpoint Study of 2 Doses of Tofacitinib in comparison to a Tumor Necrosis Factor (TNF) Inhibitor in Subject with Rheumatoid Arthritis. Pfizer. 2017, ongoing. Principal Investigator.
29. Efficacy and Safety of Sotagliflozin Versus Placebo in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents (SOTA-INS) Completed 2019. Principal Investigator.
30. LIXILAN-D (DIVERSITY): A 26-week randomized, open-label, active-controlled, 2-treatment arm, parallel-group multi-center study, comparing the Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents (LixiLan-D) Dec 2018 completed Principal Investigator.
31. Randomized, Open label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog® versus Continuous Use of NovoLog in Patients with Type 1 Diabetes Mellitus also Using Insulin Glargine. Mar 2019 ongoing. Principal Investigator.
32. A phase 3, multicenter, randomized, double-blind, placebo-controlled, active reference (adalimumab) study evaluating the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis. Ongoing Apr 2019, Principal Investigator.
33. PROMINENT prominent pemafibrate to reduce cardiovascular outcomes by reducing triglycerides in patients with diabetes. Ongoing started 2017, Principal Investigator.
34. SAPPHIRE; A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients with Chronic Kidney Disease and Hyperuricaemia, Ongoing started 2019, Principal Investigator.
35. A Randomized, Non-Inferiority, Phase 3, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women with Osteoporosis (Wearable Study) ongoing started 2020, Principal Investigator
36. AbbVie / “24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy” Started February 2020. Principal Investigator.
37. ANJ900D3501: A randomized, multicenter, double-blind, parallel-group, placebo-and comparator-controlled study to compare the glycemic effects, safety, and tolerability of metformin hydrochloride delayed-release tablets in patients with type 2 diabetes mellitus with varying renal function from normal up to CKD3B
38. D9488C00001: A Phase 3, International, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants with CKD and Hyperkalaemia or at Risk of Hyperkalaemia
39. CSL346_2001: A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade with the Monoclonal Antibody CSL346 in Subjects with Diabetic Kidney Disease
40. I8F-MC-GPHL: Efficacy and Safety of Tirzepatide Once Weekly versus Placebo in Participants with Type 2 Diabetes Who Have Obesity or Are Overweight with Weight-Related Comorbidities (SURMOUNT-2)
41. I8H-MC-BDCU A Phase 3 Multicenter Randomized Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 compared to Degludec in Participants with Type 2 Diabetes currently Treated with Basal Insulin (QWINT-3) March 2022 ongoing.
42. A randomised, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with chronic kidney disease Dec 2021 ongoing.
43. J2A-MC-GZGS A Phase 3, Open-Label Study of Once Daily LY3502970 Compared with Insulin Glargine in Adult Participants with Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk (ACHIEVE-4)