Research Study

Past Study: Pioneer 5

Study Status: CLOSED

Study Name: Pioneer 5                            

Study Focus:  Type 2 Diabetes with Kidney Impairment

 

Study Contact: To learn more, please call 1-877-854-8475 or fill out the Contact us form.

Study Purpose: To compare the effect of once-daily dosing of 14 mg oral semaglutide versus placebo,  in combination with metformin and/or sulfonylurea, basal insulin alone or metformin in combination with basal insulin in subjects with type 2 diabetes mellitus and moderate kidney impairment.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if you meet the following criteria:

     • Men or women diagnosed with Type 2 Diabetes, with kidney impairment

     • Taking a stable dose of Metformin and/or a Sulfonylurea,  Basal Insulin alone or Metformin in combination with basal insulin.

     • Hemoglobin A1c measurement between 7.0-9.5%

     • Male or Females at the age of 18 and older.

 

Study Duration: up to 33 weeks (maximum)

 

Study Procedures:

     • Physical exam, height, weight, vital signs, EKG, medical history and current medication

     • Blood and urine collections

     • Questionnaires, eye exam, collection of glucose diaries

     • Study Drug administration

 

Study Commitment:

     • Total of 8 clinic visits, including a screening visit

     • In addition 1- 6 phone calls depending what medications you are on over the 33 weeks.

All visits are completed at The Florida Hospital Diabetes Institute, 2415 North Orange Ave., Suite 501, Orlando Florida 32804.  

 

Compensation offered?: Yes, up to $715

 

This study is being conducted under the direction of Richard Pratley, MD at 301 East Princeton Street, Orlando, Florida 32804.