Berman Center Home What We Do Studies and Trials

CAPPS,
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy
Sponsor
     Ortho-McNeil Pharmaceutical Inc.
Berman Center Investigator
     Site Principal Investigator: William David, MD, PhD
Berman Center Site Coordinator
     Shirley Conn, RN, 612-341-7907
Description
The objective of this study is to compare the analgesic efficacy and safety of tramadol HCl and acetaminophen versus placebo for the treatment of painful diabetic neuropathy.

ACCORD, Action to Control Cardiovascular Risk in Diabetes
     Substudies: ACCORD-Mind and ACCORD-Eye
Sponsor and Initiator
     National Heart Lung and Blood Institute (NHLBI), U.S. National Institutes of Health (NIH)
Minnesota/Iowa Network Principal Investigators
     Richard Bergenstal, MD, Minnesota International Diabetes Center
     Richard Grimm, MD, PhD, Berman Center for Outcomes and Clinical Research
Minnesota/Iowa Network Project Manager
     Brenda Kirpach, CCRA, Berman Center for Outcomes and Clinical Research
Description
This trial addresses the challenges to cardiovascular health of persons with type 2 diabetes by testing three complementary medical treatment strategies. Participants are randomly assigned to a treatment regimen involving either aggressive or standard control of blood sugar. Then, depending on their blood pressure and cholesterol levels, they are assigned to either a blood pressure intervention or blood fat intervention.

ORIGIN, Outcome Reduction with Initial Glargine Intervention
Sponsor
     Aventis
Principal Investigator for U.S. Regional Coordinating Center
     Jeffery Probstfield, MD, University of Washington School of Medicine
Co-Principal Investigators
     Hertzel Gerstein, MD, Professor of Medicine and Chief of Division of Endocrinology
     McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
     Salim Yusuf, MD, Professor of Medicine and Chief of Division of Cardiology
     McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
Berman Center Co-Investigators
     Sidney A. Jones, MD, Hennepin Faculty Associates Division of Endocrinology, Diabetes, and Metabolism
     Sandra Graham, NP
Description
ORIGIN is a 2x2 factorial study investigating the prevention of cardiovascular morbidity and mortality in people with type II diabetes, impaired glucose tolerance, and/or fasting glucose ≥110 mg/dL. The two factors are insulin glargine (Lantus) (variable dose vs. standard care), and omega-3 fatty acid (865mg vs. placebo). Participants are randomized to one of the four possible treatment combinations.

DREAM, Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication
Sponsor
     Aventis
Principal Investigator for U.S. Regional Coordinating Center
     Jeffery Probstfield, MD, University of Washington School of Medicine
Co-Principal Investigators
     Hertzel Gerstein, MD, Professor of Medicine and Chief of Division of Endocrinology
     McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
     Salim Yusuf, MD, Professor of Medicine and Chief of Division of Cardiology
     McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
Berman Center Investigator
     Sarah Kempainen, MD
Berman Center Coordinator
     Sandra Graham, NP, 612-341-7923
Description
DREAM is an international, multi-center, randomized, double-blinded, placebo-controlled trial involving 4,000 participants at high risk for developing type II diabetes mellitus. Participants receive ramipril (ACE-I) or placebo and rosiglitazone (TZD) or placebo (therefore, there are 4 treatment combinations possible). The goal is to determine which group has a lower prospective incidence of DM. The study also collects observational data useful for establishing epidemiological associations between cardiovascular disease and type II diabetes mellitus.
 
 
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