Dr. Rodica Pop-Busui has concentrated her scholarship and research efforts on translational and clinical research focused on understanding the mechanisms underlying the development of diabetes and prediabetes complications. The design and execution of her clinical trials are used to test novel therapies that target mechanisms for preventing chronic complications in patients with type 1 and type 2 diabetes. As a result of her efforts, Dr. Pop-Busui's research has been funded by divisions of the U.S. National Institutes of Health (NIH), such as the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), as well as the Juvenile Diabetes Research Foundation (JDRF), Centers for Disease Control and Prevention (CDC), private foundations, and industries.
Current Clinical Trials & Studies
The Pop-Busui research team is actively involved in many studies and trials in patients with diabetes and diabetic complications, as well as novel technologies for improving diabetes care, in various stages of completion. Below are examples of a broad spectrum of clinical trials evaluating novel therapies and technologies for people with diabetes for which we are still recruiting patients. If you, or someone you know, would like to see if they are eligible to participate, please select the study title below to get more information.
There are many steps to doing research including writing the proposal; applying for funding; getting approval for the study methods; recruiting, screening, and treating groups of patients; collecting the lab results; analyzing the data; and writing the findings for publication. The below studies are in various stages of this process and may not be recruiting new participants at this time.
Type 1 Diabetes
Upcoming Trials & Studies
Efficacy, Safety, and Pharmacokinetics of LX9211 in Patients with Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1)
A phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period. Information: Cynthia Plunkett at [email protected] or 734-936-8065.
Ongoing Trials & Studies – Recruiting
Incidence and Predictors of Acute and Chronic Complications in Patients with Diabetes and Severe COVID-19
This study involves all patients of the Michigan Medicine COVID-19 Cohort (M2C2) that were admitted to the University of Michigan with severe COVID-19 infection. We previously collected baseline samples from these individuals when they were in the hospital. In these participants, we observed a significantly higher risk for severe acute complications in patients with diabetes compared to those without diabetes. Thus, we want to understand what drives this risk, as well as to understand the long term complications of COVID-19 infection in patients with diabetes. The objectives of this study are to invite all surviving M2C2 participants for an in-person visit, to measure inflammatory markers and renal, neural, and cardiovascular damage biomarkers. We will also comprehensively phenotype participants for diabetic complications outcomes including diabetic kidney disease, diabetic neuropathy, and cardiovascular disease. Participants will also be requested to fill out questionnaires to assess psychosocial metrics. This study will generate the knowledge base required for much needed, and immediately applicable clinical guidelines for both risk stratification of patients at disease onset, but also management of current and future COVID-19 T2D patients after hospital discharge. If you were enrolled in M2C2 while in the hospital being treated for COVID-19, have diabetes, and are interested in participating, please contact Aaron Burant at [email protected] or (734) 615-0552.
JDRF Center of Excellence - Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes - This is a center grant focusing on patients with type 1 diabetes (T1D) to comprehensively study and understand risk factors and protective mechanisms for diabetes chronic complications; susceptibility to hypoglycemia and improvement with the use of advanced diabetes technologies; the heterogeneity in the risk of chronic complications; and minimize the psychosocial impact of type 1 diabetes. Information: Jacob Reiss at [email protected] or (734) 763-0177.
C-Myc - Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers – C-Myc and Phosphorylated Glucocorticoid Receptor - This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound’s edge. An additional tissue specimen will be collected at 4 weeks. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing. Information: Aaron Burant at [email protected] or (734) 615-0552.
TEWL - Trans-Epidermal Water Loss as a Predictive Marker for Diabetic Foot Ulcer Recurrence - This is a multi-center study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Participants will be enrolled after closure of their DFU. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site. This study is part of the Diabetic Foot Consortium. Information: Aaron Burant at [email protected], (734) 615-0552 or Jacob Reiss at [email protected], (734) 615-0552.
TINSAL - Targeting Inflammation with Salsalate in Type 1 Diabetes Neuropathy - This phase III, multi-site, randomized, double-blind, placebo-controlled clinical trial examines whether a 12-month course of the drug salsalate will prevent the progression of diabetic neuropathy in subjects with type 1 diabetes and mild diabetic neuropathy. Information: Jacob Reiss at [email protected] or (734) 763-0177. View study on U-M Health Research.
Evaluation of Cardiovascular Outcomes with Semaglutide in Patients with Prior MI/Stroke/Symptomatic PAD and Overweight or Obesity - The objective of this study is to investigate the long-term effects of semaglutide in patients who are overweight or obese. Information: Cynthia Plunkett at [email protected] or 734-936-8065.
Trial to Assess Chelation Therapy (TACT2) - This is a randomized, double-blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction (MI). Information: Cynthia Plunkett at [email protected] or 734-936-8065.
Ongoing Trials & Studies – Not Recruiting
Preventing Early Renal Loss in Diabetes Follow-Up Study (PERLage)
PERLage is an observational follow-up of the PERL trial cohort, a cohort of subjects with type 1 diabetes who participated in a 3-year clinical trial investigating whether the uric acid lowering drug allopurinol can preserve kidney function among type 1 diabetic patients.
Safety and Effectiveness Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Adult and Adolescent Subjects with Type 1 Diabetes (CIP 321)
The objective of this study is to investigate the advanced hybrid closed loop system in adult and adolescent patients with type 1 diabetes.
EDIC - The Epidemiology of Diabetes Interventions and Complications
This observational study examines the risk factors associated with the long-term complications of type 1 diabetes. The study began in 1994 and follows the 1,441 participants previously enrolled in the Diabetes Control and Complications Trial (DCCT).
Published Outcomes from Recent Trials & Studies
PERL - Preventing Early Renal Loss in Type 1 Diabetics - The PERL trial tested whether a known drug for gout - allopurinol - slows or prevents kidney disease in patients with type 1 diabetes. The trial found that reducing levels of uric acid in the blood does not guard against complication in patients with type 1 diabetes. Read more: “Serum Urate Lowering with Allopurinol and Kidney Function in Type 1 Diabetes”. NEJM, 2020. PMID: 32579810.
Wireless Innovation for Seniors with Diabetes Mellitus (WISDM). The primary objective of the trial was to determine if continuous glucose monitoring (CGM) can reduce hypoglycemia and improve quality of life in older adults with type 1 diabetes. The trial showed that the use of CGM reduces serious levels of hypoglycemia (low blood sugar), compared with standard monitoring by daily use of blood glucose finger-stick test strips. In addition, CGM users saw significant reductions in the amount of time spent in hypoglycemia and in the occurrence of severe hypoglycemic events while also improving their hemoglobin A1C levels and overall glucose control. Read more: “Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults with Type 1 Diabetes: A Randomized Clinical Trial”. JAMA, 2020. PMID: 32543682.
Bydureon in Type 1 Diabetes - This phase II trial examined the effects of the drug exenatide (Bydureon), a drug approved to treat high blood sugar in patients with type 2 diabetes, on measures of glucose control in patients with type 1 diabetes. Read more: “Exenatide Extended Release in Patients With Type 1 Diabetes With and Without Residual Insulin Production”. Diabetes, Obesity and Metabolism, 2020. PMID: 32573927.
View more of Dr. Pop-Busui’s publications.
Type 2 Diabetes
Upcoming Trials & Studies
Efficacy, Safety, and Pharmacokinetics of LX9211 in Patients with Diabetic Peripheral Neuropathic Pain (RELIEF-DPN 1)
A phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy over an 11 week assessment period. Information: Cynthia Plunkett at [email protected] or 734-936-8065.
Ongoing Trials & Studies – Recruiting
Incidence and Predictors of Acute and Chronic Complications in Patients with Diabetes and Severe COVID-19
This study involves all patients of the Michigan Medicine COVID-19 Cohort (M2C2) that were admitted to the University of Michigan with severe COVID-19 infection. We previously collected baseline samples from these individuals when they were in the hospital. In these participants, we observed a significantly higher risk for severe acute complications in patients with diabetes compared to those without diabetes. Thus, we want to understand what drives this risk, as well as to understand the long term complications of COVID-19 infection in patients with diabetes. The objectives of this study are to invite all surviving M2C2 participants for an in-person visit, to measure inflammatory markers and renal, neural, and cardiovascular damage biomarkers. We will also comprehensively phenotype participants for diabetic complications outcomes including diabetic kidney disease, diabetic neuropathy, and cardiovascular disease. Participants will also be requested to fill out questionnaires to assess psychosocial metrics. This study will generate the knowledge base required for much needed, and immediately applicable clinical guidelines for both risk stratification of patients at disease onset, but also management of current and future COVID-19 T2D patients after hospital discharge. If you were enrolled in M2C2 while in the hospital being treated for COVID-19, have diabetes, and are interested in participating, please contact Aaron Burant at [email protected] or (734) 615-0552.
C-Myc - Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers – C-Myc and Phosphorylated Glucocorticoid Receptor - This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound’s edge. An additional tissue specimen will be collected at 4 weeks. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing. Information: Aaron Burant at [email protected] or (734) 615-0552.
TEWL - Trans-Epidermal Water Loss as a Predictive Marker for Diabetic Foot Ulcer Recurrence - This is a multi-center study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Participants will be enrolled after closure of their DFU. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site. This study is part of the Diabetic Foot Consortium. Information: Aaron Burant at [email protected], (734) 615-0552 or Jacob Reiss at [email protected], (734) 615-0552.
Evaluation of Cardiovascular Outcomes with Semaglutide in Patients with Prior MI/Stroke/Symptomatic PAD and Overweight or Obesity - The objective of this study is to investigate the long-term effects of semaglutide in patients who are overweight or obese. Information: Cynthia Plunkett at [email protected] or 734-936-8065.
Long-Term Effects of Semaglutide on Diabetic Retinopathy in Subjects with Type 2 Diabetes (FOCUS), Trial Phase 3b - The objective of FOCUS is to investigate the safety of semaglutide on retinal complications in patients with type 2 diabetes. Information: Cynthia Plunkett at [email protected] or 734-936-8065.
Trial to Assess Chelation Therapy (TACT2) - This is a randomized, double-blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction (MI). Information: Cynthia Plunkett at [email protected] or 734-936-8065.
Ongoing Trials & Studies – Not Recruiting
Glycemia Reduction Approaches for Diabetes: A Comparative Effectiveness Study
This is a large comparative effectiveness trial evaluating the effects on four of the most widely used diabetes drugs in combination with metformin in maintaining glucose control and prevent complications in people with type 2 diabetes. Michigan Medicine recruited over 160 participants out of more than 5,000 nationwide. The trial is expected to conclude in 2021.
Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT)
The primary scientific aim of the PROMINENT study is to assess whether treatment with the selective peroxisome proliferator activated receptor modulator alpha (SPPARM-α), pemafibrate, will prevent myocardial infarction (MI), ischemic stroke, unstable angina requiring unplanned revascularization, and cardiovascular (CV) death in adults with type 2 diabetes (T2D) who have elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDL-C) levels and are at high risk for future CV events.
MOBILE - Continuous Glucose Monitoring in T2D Basal Insulin Users
This study compares the glycemic and quality of life benefits of diabetes management using the Dexcom G6 continuous glucose monitoring versus self-monitored blood glucose made by study participants and their primary care physicians. Decisions will be based on insights from real-time use and retrospective insights, determined during remote visits.
Published Outcomes from Recent Trials & Studies
Evaluation of Exenatide in Patients with Diabetic Neuropathy - This trial evaluated whether exenatide, a medication that is used to treat high blood sugar, may reverse signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy. Read more: “Effects of Exenatide on Measures of Diabetic Neuropathy in Subjects with Type 2 Diabetes: Results From an 18-month Proof-Of-Concept Open-Label Randomized Study”. Journal of Diabetic Complications, 2015. PMID 26264399.
GRADE - Glycemia Reduction Approaches for Diabetes: A Comparative Effectiveness Study - This is a large comparative effectiveness trial evaluating the effects on four of the most widely used diabetes drugs in combination with metformin in maintaining glucose control and prevent complications in people with type 2 diabetes. Michigan Medicine recruited over 160 participants out of more than 5,000 nationwide. The trial is expected to conclude in 2021. Dr Pop-Busui led a group of GRADE investigators in analyzing the prevalence of diabetes chronic complications in this large cohort. Read more: “Prevalence of Microvascular and Macrovascular Disease in the Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) Study Cohort”. Diabetes Research and Clinical Practice, 2020. PMID: 32450102
View more of Dr. Pop-Busui’s publications.
Past Studies & Trials
Dr. Pop-Busui has participated in some of the most important diabetes studies to date, the results of which have changed the ways in which diabetes is managed around the world. Many of the studies were funded by the U.S. National Institutes of Health (NIH), as well as other top diabetes research organizations such as the Juvenile Diabetes Research Foundation (JDRF).
Closed Research Studies & Trials
- Multi-Center Trial in Adult and Pediatric Patients with Type 1 Diabetes Using Hybrid Closed Loop System at Home (CEP 304)
- PERL - Preventing Early Renal Loss in Type 1 Diabetics
- Wireless Innovation for Seniors with Diabetes Mellitus (WISDM)
- Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)
- Bydureon in Type 1 Diabetes
- Antipsychotic and Folate Pharmacogenomics
- Multinational Collaborative Evaluation of Corneal Confocal Microscopy as a Surrogate Endpoint for the Identification and Prediction of Diabetic Neuropathy in Type 1 Diabetes
- Post Approval Study of the TS (Threshold Suspend) Feature with a Sensor-Augmented Pump System
- CACTI - Complications and Comorbidities of Type 1 Diabetes
- Tissue-Specific Metabolic Reprogramming in Diabetic Complications
- CAN - Cardiac Autonomic Neuropathy and Myocardial Dysfunction in Type 1 Diabetes
- DEVOTE - Degludec Cardiovascular Outcomes Trial
- Evaluation of Exenatide in Patients with Diabetic Neuropathy
- SEARCH - Surveillance, Natural History, Quality of Care and Outcomes of Diabetes Mellitus with Onset in Childhood and Adolescence
- REPLACE - Adjunction Versus Replacement Continuous Glucose Monitoring (CGM)
- EDIC - Epidemiology of Diabetes Interventions and Complications
- TINSAL-T2D - Targeting Inflammation with Salsalate in Type 2 Diabetes
- ACCORD - Action to Control Cardiovascular Risk in Diabetes
- BARI 2D - Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics Trial
- JDRF Center for the Study of Complications in Diabetes
- Oxidative Stress and Cardiac Denervation in Type 1 Diabetes
View Dr. Pop-Busui’s CV for a complete list of her grants and research projects.
