The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
962
Administered orally
Administered orally
Change from Baseline in Hemoglobin A1c: (HbA1c)
Time frame: Baseline, Week 40
Change from Baseline in HbA1c
Time frame: Baseline, Week 40
Percentage of Participants Who Achieved HbA1c <7.0% (53 millimole/mole(mmol/mol))
Time frame: Week 40
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)
Time frame: Week 40
Percentage Change from Baseline in Body Weight
Time frame: Baseline, Week 40
Change from Baseline in Body Weight
Time frame: Baseline, Week 40
Percentage Change from Baseline in Non-High-Density Lipoprotein (non-HDL)-Cholesterol
Time frame: Baseline, Week 40
Percentage Change from Baseline in Triglycerides
Time frame: Baseline, Week 40
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 40
Change from Baseline in Fasting Serum Glucose
Time frame: Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5% from Baseline
Time frame: Baseline to Week 40
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alliance Research Institute - Canoga Park
Canoga Park, California, United States
Ark Clinical Research
Long Beach, California, United States
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States
Wolverine Clinical Trials
Santa Ana, California, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Institute of Endocrinology Diabetes, Health & Hormone
Stockbridge, Georgia, United States
Elite Clinical Trials
Rexburg, Idaho, United States
Accellacare - DuPage
Lombard, Illinois, United States
Tandem Clinical Research
Marrero, Louisiana, United States
St. Vincent Healthcare
Billings, Montana, United States
...and 64 more locations
Percentage of Participants Who Achieved Weight Loss of ≥10% from baseline
Time frame: Baseline to Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15% from baseline
Time frame: Baseline to Week 40
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 40
Percentage Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 40
Change from Baseline in Short Form 36 Version 2 (SF-36-v2) Acute Form Domain Summary Scores
Time frame: Baseline, Week 40
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Change (DTSQc) Scores
Time frame: Baseline, Week 40