Ground Truth
Inclusion Criteria:Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin.
Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening.Have HbA1c >6.5% to ≤11% at screening visit.
If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5 % to ≤9%.Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).Exclusion Criteria:Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.A history of, or at risk for pancreatitis.Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening.A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg.Active or treated cancer.A blood disorder where an accurate HbA1c may not be obtainable.A female of childbearing age, sexually active and not on birth control.Pregnant or plan to be pregnant during the study, or breastfeeding.Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.Using prescription weight loss medications in the last 30 days, or plan to use.Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.
Prediction
Inclusion Criteria:
- Have type 2 diabetes, treated with diet and exercise, with or without metformin (≥1000 mg/day) and/or basal insulin.
Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening.
- Have HbA1c >6.5% to ≤11% at screening visit.
If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5% to ≤9%.
- Have a BMI >85 percentile for age, gender, and body weight ≥50 kilograms (110 pounds).
- Both the child or adolescent with T2DM and a parent or legal guardian are able to understand and fully participate in the activities of the clinical trial and sign their assent and consent, respectively.
Exclusion Criteria:
- Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.
- A history of, or at risk for pancreatitis, or known gallbladder disease, or clinical hypertriglyceridemia associated with pancreatitis (>11.2 mmol/L or >1000 mg/dL).
- Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia, or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening.
- A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100mmHg.
- Active or treated cancer.
- A blood disorder where an accurate HbA1c may not be obtainable.
- A female of childbearing age, sexually active and not on birth control.
- Pregnant or plan to be pregnant during the study, or breastfeeding.
- Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit.
- Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.
- Using prescription weight loss medications in the last 30 days, or plan to use.
- Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if the doses have changed within the last 3 months.
- Have a clinically significant gastric emptying abnormality, in the opinion of the investigator, or previous gastric bypass.
- Have an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m².
- Are currently enrolled in any other clinical trial involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.