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Clinical Trials

 

Current Diabetes Studies | Current Metabolic Studies | Completed Studies


Current Diabetes Studies

Diabetes Research Registry
Aims: To collect clinical information related to diabetes for researchers to study and learn more about diabetes. Additionally, the registry is being created to inform participants of ongoing and future diabetes related studies which they may be eligible to participate in.
Diagnosis: Any type of diabetes (type 1, type 2, gestational, etc.)
Principal Investigator: Liana Billings, MD
IRB Approval Number: EH15-309
Sponsor: N/A
Contact: Interested patients may contact diabetes research staff at 847.663.8510 or email diabetesresearch@northshore.org
Open to Enrollment: Yes

Find MODY - A Study to FIND Individuals with Maturity-onset Diabetes of the Young (MODY) Who Have Been Misdiagnosed as Type 1 or Type 2 Diabetes
Aims: This is a 3-phase study to FIND individuals with Maturity-onset Diabetes of the Young (MODY) who have been misdiagnosed as Type 1 or Type 2 Diabetes and implement gene-directed pharmacotherapies as well as identify new causal mutations and medical therapies. Currently, the study is in phase I where researchers are using the electronic medical record to identify and characterize individuals who are high risk for MODY. Phase II will be started once phase I is completed. Patients identified at high risk from phase I will be contacted to fill out a genetic survey, complete laboratory testing, and obtain genetic testing for MODY.
Diagnosis: Type 1 and Type 2
Principal Investigator: Liana Billings, MD
IRB Approval Number: EH14-424
Sponsor: N/A
Contact: For the FIND MODY trial we will contact participants who qualify.  If you believe you may be at risk of having  MODY or neonatal diabetes, please contact diabetes research staff at 847.663.8510 or email diabetesresearch@northshore.org. We can make arrangements for you to be evaluated in the Personalized Medicine in Diabetes Consultation Clinic.
Open to Enrollment: Yes

FLOW- A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
Aims:
 To see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes.
Diagnosis: Type 2 diabetes and chronic kidney disease
Principal Investigator: Liana Billings, MD
IRB Approval Number: EH19-178
Sponsor:  Novo Nordisk
Contact: Cheryl Auston at 847.663.8524 or causton@northshore.org
Open to Enrollment: No

REALYSE- A Research Study to See How Oral Semaglutide Works Compared to Other Oral Diabetes Medications in People With Type 2 Diabetes
Aims:
 To see if oral semaglutide decreases HbA1c more than other available oral diabetes medications in a real-world setting.
Diagnosis: Type 2 diabetes
Principal Investigator: Liana Billings, MD
IRB Approval Number: EH20-201
Sponsor:  Novo Nordisk
Contact: Holly Jacobs at 847.663.8345 or hjacobs@northshore.org
Open to Enrollment: Yes

 

COMBINE 3- A Research Study to See How once per week IcoSema Works Compared to Daily Basal Insulin with Mealtime Insulin Three Times per Day in People With Type 2 Diabetes
Aims:
  
To see if IcoSema (insulin icodec plus semaglutide combination medication) works as well or better than basal bolus insulin in type 2 diabetes.
Diagnosis: 
Type 2 diabetes
Principal Investigator:
 Liana Billings, MD
IRB Approval Number: 
EH21-364
Sponsor:  
Novo Nordisk
Contact: 
Cheryl Auston at 847.663.8524 or causton@northshore.org
Open to Enrollment: 
Yes

COMBINE 2- A Research Study to See How once per week IcoSema Works Compared to Semaglutide once per week in People With Type 2 Diabetes
Aims:
  
To see if IcoSema (insulin icodec plus semaglutide combination medication) works as well or better than semaglutide alone in type 2 diabetes.
Diagnosis: 
Type 2 diabetes
Principal Investigator:
 Liana Billings, MD
IRB Approval Number: 
EH22-076
Sponsor:  
Novo Nordisk
Contact: 
Cheryl Auston at 847.663.8524 or causton@northshore.org
Open to Enrollment: 
Yes

CPMP - Master protocol for clinical trials of multiple interventions for the treatment of chronic pain
Aims:
 To see if study drug improves pain outcomes for patients with painful diabetic peripheral neuropathy.
Diagnosis: painful diabetic peripheral neuropathy
Principal Investigator: 
Liana Billings, MD
IRB Approval Number: 
EH22-006
Sponsor:  Eli Lilly

Contact:  
Linda McCaughey at 847.663.8510 or lmccaughey@northshore.org
Open to Enrollment:  
Yes


Current Metabolic Studies

ESSENCE - The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis
Aims: To see if semaglutide may improve liver fibrosis in patients with non-alcoholic steatohepatits and liver fibrosis.
Diagnosis: History of non-alcoholic steatohepatits
Principal Investigator: Liana Billings, MD
IRB Approval Number: EH21-067
Sponsor:  Novo Nordisk
Contact:  Cheryl Auston at 847.663.8524 or causton@northshore.org
Open to Enrollment:  Yes

ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
Aims:
 To see if ziltivekimab may reduce the risk of having cardiovascular events in patients with inflammation, decreased kidney function and prior cardiovascular disease.
Diagnosis: History of a heart attack, stroke, peripheral vascular disease or stenosis and reduced kidney function
Principal Investigator: 
Liana Billings, MD
IRB Approval Number: 
EH21-240
Sponsor:  
Novo Nordisk
Contact:  
Linda McCaughey at 847-663-8510 or lmccaughey@northshore.org
Open to Enrollment:  
Yes

NATiV3 - The effect of lanifibranor in subjects with non-cirrhotic non-alcoholic steatohepatitis
Aims: To see if lanifibranor may improve liver fibrosis in patients with non-alcoholic steatohepatits and liver fibrosis.
Diagnosis: History of non-alcoholic steatohepatits
Principal Investigator: Liana Billings, MD
IRB Approval Number: EH21-283
Sponsor:  Inventiva
Contact:  Lynn Tucker at 847.663.8344 or  ltucker@northshore.org
Open to Enrollment:  Yes

SELECT - Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity
Aims:
 To see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease.
Diagnosis: History of a heart attack, stroke or peripheral vascular disease
Principal Investigator:
Liana Billings, MD
IRB Approval Number:
EH18-290
Sponsor:  
Novo Nordisk
Contact: 
Linda McCaughey at 847.663.8510 or lmccaughey@northshore.org
Open to Enrollment: 
No

TARGET-NASH - A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Seatohepatitis (NASH)
Aims:
 To collect clinical information related to diabetes for researchers to study and learn more about NAFL and NASH.
Diagnosis: Non-alcoholic steatohepatitis or Non-alcoholic fatty liver disease
Principal Investigator: Liana Billings, MD
IRB Approval Number: EH20-060
Sponsor:  Target RWE
Contact:  Lynn Tucker at 847-663-8344 or ltucker@northshore.org
Open to Enrollment:  Yes


Completed Studies

SURPASS-4 - A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants with Type 2 Diabetes and Increased Cardiovascular Risk

Amplitude-D -Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

COACH- Continuous Monitoring and Control of Hypoglycemia

STEP3- Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

SWITCH PRO - A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes

Mylan - A Randomized, Multicenter, Open-Label, Parallel-Group Clinical Study Comparing the Safety and Efficacy of MYL-1601D with NovoLog® in Type 1 Diabetes Mellitus Patients

CONCLUDE - A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Pioneer 1- Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

SUSTAIN- Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

SWITCH 1 - A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes

PHARMGen- Patients with Hyperglycemia Assessed for Response to Medications by Genetics

DUAL IX - A clinical trial comparing glycemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus

Dual VII- Insulin Degludec/Liraglutide (IDegLira) versus basal-bolus Therapy: A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutid (IDegLira) Versus Basal-bolus Therapy in Subjects with Type 2 Diabetes

DIaMonD- Multiple Daily Injection and Continuous glucose Monitoring in Diabetes 

Adjunct Two- The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes