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Type 2 Diabetes Studies

Seeking Participants

"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.


"Clinical Protocol to Investigate the Efficacy of Amlexanox for Treatment of Glucose and Lipid Abnormalities in Obese Type 2 Diabetes"

Purpose: To find out how an investigational medicine, Amlexanox — formerly used for asthma and canker sores — can improve type 2 diabetes, insulin resistance, obesity, and non-alcoholic fatty liver disease (NAFLD). This is a translational study that is completely home-grown here at UM. Amlexanox is taken orally in a pill three times a day. We plan to continue therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. We will evaluate the changes in metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body). Seven eligible subjects in this study will also be evaluated for a change in liver disease by a liver biopsy.

IRB#: HUM00065177            
(click on the IRB# to see the full study description in the UM Clinical Studies Database)                                                                                                                         
PI: Dr. Elif Oral
Study Coordinator: Adam Neidert, (734) 615-0539 or aneidert@med.umich.edu

ELIGIBILITY CRITERIA:

  • Diagnosed with type 2 diabetes or obesity
  • Between 18 to 60 years of age
  • Presence of advanced liver disease
  • No diabetes medication other than first-line oral medications (no insulins)
  • HbA1c less than 9.5 %
  • Alcohol consumption of less than 40g a week
  • A liver ultrasound to confirm fatty infiltration of the liver
  • Currently does not have Acquired Immune Deficiency Syndrome ( AIDS )
  • Body Mass Index (BMI) is between 27 and 36
  • Must not be pregnant at the time of enrollment
  • Cannot be breastfeeding

EXCLUSION CRITERIA:

  • For other eligibility and exclusion criteria, inquire with the study coordinator. 

Compensation: $750 to $900


"EndoBarrier: A Novel Therapy for Type 2 Diabetes in Obese Adults"

Purpose: To evaluate the safety and initial efficacy of the EndoBarrier Gastrointestinal Liner System in uncontrolled Type 2 diabetic subjects who are also obese. The study will look to confirm whether the device can help control diabetes. UM has been selected as one of the 20 sites participating in a pivotal U.S. trial testing the novel device (the Endobarrier) as a new therapy for type 2 diabetes. Endobarrier is a duodenal sleeve that is about 2 feet long that gets placed into the duodenum and early part of the jejunum in the small intestine. The device may create at least part of the effects of gastric bypass surgery that allows the diabetes to go in remission. The device will be placed by Grace Elta, M.D., and Erik-Jan Wamsteker, M.D., of Gastroenterology Medicine at UM. Patients will be randomly assigned either to the actual device group or the “sham” operation group with a  2:1 ratio. The “sham” operation group will have a chance to receive the actual device after the first year of the study.

IRB#: HUM00070226     
(click on the IRB# to see the full study description in the UM Clinical Studies Database)                                                                                                                                
PI: Dr. Elif Oral
Study Coordinator: Tim Muth, (734) 615-8914 or tmuth@med.umich.edu

ELIGIBILITY CRITERIA:

  • Diagnosed with type 2 diabetes or obesity
  • Between 21 and 65 years of age
  • Not on insulin and blood sugar is not well-controlled

EXCLUSION CRITERIA:

  • For other eligibility and exclusion criteria, inquire with the study coordinator. 

Compensation: $675 to $775


"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


 

Volunteer for a Clinical Study!

For general questions about our clinical studies, send email to diabetes-studies@umich.edu
or call (734) 647-5400.