"Glycemia Reduction Approaches in Diabetes — A Comparative Effectiveness Type 2 Diabetes Study (GRADE)"

Purpose: To compare effectiveness of four commonly prescribed anti-diabetic medications to control blood sugar levels when combined with Metformin.

IRB#: HUM00066643                                                                                                                                    
PIs: Dr. William Herman and Dr. Rodica Pop-Busui
Study Coordinators: Cathy Martin, RN, CDE,  martinc@umich.edu and Alisha Beaton, abeaton@umich.edu or toll-free: (855) 455-6559

ELIGIBILITY CRITERIA:

The GRADE study is for people:

• Diagnosed with type 2 diabetes, first diagnosed at age 30 or above (Native Americans must have had diabetes diagnosed at age 20 or above)
• Who have had type 2 diabetes for less than 5 years
• Who take metformin for diabetes and no other diabetic medications 
• Have an A1c equal to or greater than 6.8% (this can be measured at the screening visit)
• Who are willing to take a randomly assigned medication in addition to metformin.  Two of the medications require daily self-injection. 
• Who are willing to check their blood sugars daily if required.

EXCLUSION CRITERIA:

People cannot be in the study if:

• They take any medication for blood sugar control other than metformin
• They have been treated for cancer in the last five years (except for treatment of non-melanoma skin cancers)
• They regularly use oral or injectable steroids (inhaled steroids may be acceptable).  They have had or are planning to have weight loss (bariatric) surgery.  They have had a heart attack, stroke, or other major cardiovascular event in the past year.

Other eligibility and exclusion criteria apply and will be reviewed at the time of screening. 

Compensation: Eligible volunteers will receive diabetes care, metformin, assigned study medication and all necessary supplies without cost for up to 7 years.

"Cardiovascular Outcomes Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients with a Recent Acute Coronary Syndrome (ACE) Event and Type 2 Diabetes Mellitus"

Purpose:
If the study drug Aleglitazar can reduce the risk of having a cardiovascular event in men or women with type 2 diabetes such as heart attack or stroke. Also, how the study drug effects blood sugar levels and cholesterol levels.    

IRB#: HUM00040196
Principal Investigator: Rodica Pop-Busui, MD, PhD
Study Coordinator: Cynthia Plunkett, RNC, CCRC, 734-936-8065 or cplunket@umich.edu
Sponsored by: Hoffmann-LaRoche Inc.

ELIGIBILITY CRITERIA:

• This study is seeking:  Males or females with type 2 diabetes who have been hospitalized for an acute coronary syndrome event (heart attack, unstable chest pain) within the preceding 6 weeks
• Age range: 18 years and older
• Medication: Cannot be taking oral steroids or fibrate drugs

Exclusion list is long and includes:

• Cannot have cancer with the exception of basal-cell occurring >2 years prior to participation
• Cannot have any life-threatening illness
• Cannot have elevated triglycerides >400
• Cannot have congestive heart failure class II-IV
  

All clinic visits are completed at Domino's Farms.

All study related tests and procedures are free. Subjects receive a new glucose meter and glucose strips for the duration of the study.

"Epidemiology of Heterogeneity in Type 2 Diabetes"

IRB#: HUM00008813
(click on the IRB# to see full study description in the UM Clinical Studies Database)

Principal Investigator: Massimo T. Pietropaolo, MD
Study Coordinators: Cynthia Plunkett, RNC, CCRC, 734-936-8065 or cplunket@umich.edu

ELIGIBILITY CRITERIA:

• Age range: 40–65 years old
• This study is seeking: Patients with specified condition (type 2 diabetes)

Other eligibility factors:

• Be diagnosed with type 2 diabetes
• Be on insulin therapy or metformin or combined insulin and metformin therapy
• Cannot be treated with oral TZD agents
• Have no history of liver disease
• Must not be pregnant

Compensation: Compensation for completion of study varies, depending on extent of involvement in the study.

"Studying a Treament Improving Neuropathy in Type 2 Diabetes"

IRB#: HUM00018940
(click on the IRB# to see full study description in the UM Clinical Studies Database)

Principal Investigator: Rodica Pop-Busui, MD, PhD
Study Coordinator: Cathy Martin, MS, APRN, BC-ADM, CDE, 734-936-6465 or martinc@umich.edu

ELIGIBILITY CRITERIA:

• Age range: 18–70 years old
• Medication: Taking medication
• This study is seeking: Patients with specified condition (type 2 diabetes)

Other eligibility factors:

• HbA1c between 7 and 10%
• Not taking any of the following medications: Insulin, Byetta, Januvia
• Mild to moderate peripheral neuropathy

Compensation: $25.00 per visit