SOLSTICE: A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults with Type 2 Diabetes Mellitus
-
Enrollment
This study is currently enrolling. -
Research Area
Translational Research -
Location
-
Principal Investigator
-
Sponsor
AstraZeneca
Study Purpose: The purpose of this study is to evaluate if the study medication AZD5004 can help improve glycemic control in persons with type 2 diabetes in conjunction with diet and exercise as compared to oral semaglutide. Study medication is an oral tablet and is taken daily.
To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if
you meet the following criteria:
Study Duration: 26 Weeks
Study Commitment: 16 outpatient visits to our research clinic
Age: 18+ years old
Sex: Male and Female
Conditions/Eligibility:
-Type 2 diabetes for at least 6 months, treating it with diet/exercise or using metformin or SGLT inhibitor
-A1c between 7.0% and 10.5% inclusive
-BMI of 23 or higher
-No history of significant liver or gastrointestinal disease
-No history of hepatitis B or C, or HIV
-No use of other diabetic medication for the past 3 months
-No use of insulin for the past year
-Stable body weight for past 3 months
Study Procedures: Vital signs (blood pressure/pulse)
ECG
Height/weight measurement
Blood/urine sampling
Medical history/medication review
Physical exam
Diabetes questionnaires
Mental health questionnaire
Diabetes lifestyle training
Compensation: 1575.00
Enrollment Form
This study is currently enrolling.