Clinical Trial 17189

Miami, FL 33144

Study Summary:

Currently, there is no cure for type 2 diabetes. The goal of current treatments is to control the blood sugar levels and reduce the risk of developing complications. Treatment plans usually include diet, exercise and medications. Some people are unable to control their blood sugar levels with their current treatment plans. Therefore, there is a need for more clinical research studies to determine if new investigational medications, or co-administration of existing medications, can be effective in managing type 2 diabetes.

About the MISSION Study

  • Approximately 750 people between 18 and 79 years of age will participate in this clinical research study worldwide.
  • The purpose of this study is to determine the safety and effectiveness of a new investigational medicine. The investigational study medication is a fixed-dose combination of two approved medications.
  • Participation in a clinical research study is voluntary. You have the right to withdraw from the study at any time, for any reason. You will keep the right to the same standard care you were entitiled to prior to starting the study.

Your Role

You may qualify for this study if you:

  • Are between 18 and 79 years of age
  • Have been diagnosed with type 2 diabetes
  • Are not able to control your blood sugar with Metformin therapy alone

If you would like to participate, you will first be asked to visit a medical site near you. The purpose of this visit is to determine if you meet all of the entry criteria for the study. Qualifying to participate in the MISSION Study will depend on a range of criteria. Before deciding whether to participate, you should make sure you understand any risks associated with the study. These will be explained to you by the study doctor.

Participation in this study will last up to 19 weeks and includes 5 study visits and 1 follow-up phone call 2 weeks after your last study visit.

The study staff will perform study-related physical examinations and collect blood and urine samples for laboratory testing. You will receive study medication and study-related care at no charge. Participants will also receive a glucose meter and related supplies to measure blood sugar levels at home.

Throughout the study, you will also be asked to continue a stable dose of metforming. Participants who continue to meet their blood sugar level goals will be provided with additional therapy.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.