Raw 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.
Raw Prediction
## Amended Eligibility Criteria for Version 87 of ClinicalTrials.gov
Based on the provided text from the protocol, here are the amended eligibility criteria for version 87 of ClinicalTrials.gov:
**Inclusion Criteria:**
* **Type 2 Diabetes Mellitus (T2DM):**
* Have type 2 diabetes mellitus (T2DM) as defined by the IDF-ISPAD criteria (see Attachment 5).
* Have a HbA1c ≥6.5% to ≤11% at screening.
* Have a BMI >85% percentile of the general age- and gender-matched population for that country or region at screening.
* Body weight ≥50 kg.
* **Treatment History:**
* Currently receiving diet and exercise as part of their diabetes management.
* May be on metformin and/or basal insulin, with stable doses for at least 8 weeks prior to screening.
* Must not have received bolus insulin within 6 weeks of the screening visit, except as rescue treatment for management of acute medical conditions for a maximum of 14 days.
* Any other antihyperglycemic drugs must be discontinued for at least 3 months prior to screening.
* **Age and Gender:**
* Must be aged 10 years or older.
* **Other:**
* Must have a parent or legal guardian who understands and fully participates in the clinical trial activities.
* Must be able to provide informed consent.
**Exclusion Criteria:**
* **Known Type 1 Diabetes:**
* Have a history of type 1 diabetes (T1DM).
* **Autoantibodies:**
* Have a history of diabetes-associated autoantibodies (GAD65 or IA2) for T1DM.
* **Pancreatitis:**
* Have a history of pancreatitis, clinically significant gastric emptying abnormality, or previous gastric bypass.
* **Thyroid Conditions:**
* Have a known self or family history of multiple endocrine neoplasia (MEN) type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
* **Elevated Calcitonin:**
* Have a serum calcitonin ≥20 pg/mL at screening.
* **Kidney Function:**
* Have an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
* **Psychiatric Medications:**
* Are currently taking any psychiatric medications (including, but not limited to depression, anxiety, bipolar disease, attention deficit hyperactivity disorder [ADHD], and schizophrenia).
* Have doses of these medications not been stable (10%) for at least 3 months prior to screening.
* Have an intention to change or add new medications during the trial.
* **Weight Loss Medications:**
* Have used any prescription weight loss medication(s) within 30 days of screening or intend to use chronically during the clinical trial.
* **Pregnancy or Breastfeeding:**
* Are pregnant or plan to become pregnant during the study.
* Are breastfeeding.
* **Other:**
* Are investigator site personnel directly affiliated with this study or their immediate families.
* Are Lilly employees or employees of third-party organizations (TPOs) involved in the study.
* Have participated within the last 30 days in a 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.
* Have previously completed or withdrawn from this study or any other study investigating dulaglutide.
* Have a hemoglobinopathy or other disorder that interferes with the accurate determination of the primary endpoint.
* Have a history of severe or serious allergic reaction to study drug or other serious safety concerns.
**Important Notes:**
* This is a summary of the amended eligibility criteria based on the provided text.
* The full protocol should be consulted for complete and accurate information.
* The specific inclusion and exclusion criteria may vary depending on the version of the protocol.
* Always consult the most up-to-date version of the protocol for the most accurate information.
Processed Ground Truth
1. 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.
Processed Prediction
1. Amended Eligibility Criteria for Version 87 of ClinicalTrials.gov
2. Based on the provided text from the protocol, here are the amended eligibility criteria for version 87 of ClinicalTrials.gov:
1. Type 2 Diabetes Mellitus (T2DM):
2. Have type 2 diabetes mellitus (T2DM) as defined by the IDF-ISPAD criteria (see Attachment 5).
3. Have a HbA1c ≥6.5% to ≤11% at screening.
4. Have a BMI >85% percentile of the general age- and gender-matched population for that country or region at screening.
5. Body weight ≥50 kg.
6. Treatment History:
7. Currently receiving diet and exercise as part of their diabetes management.
8. May be on metformin and/or basal insulin, with stable doses for at least 8 weeks prior to screening.
9. Must not have received bolus insulin within 6 weeks of the screening visit, except as rescue treatment for management of acute medical conditions for a maximum of 14 days.
10. Any other antihyperglycemic drugs must be discontinued for at least 3 months prior to screening.
11. Age and Gender:
12. Must be aged 10 years or older.
13. Other:
14. Must have a parent or legal guardian who understands and fully participates in the clinical trial activities.
15. Must be able to provide informed consent.
1. Known Type 1 Diabetes:
2. Have a history of type 1 diabetes (T1DM).
3. Autoantibodies:
4. Have a history of diabetes-associated autoantibodies (GAD65 or IA2) for T1DM.
5. Pancreatitis:
6. Have a history of pancreatitis, clinically significant gastric emptying abnormality, or previous gastric bypass.
7. Thyroid Conditions:
8. Have a known self or family history of multiple endocrine neoplasia (MEN) type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
9. Elevated Calcitonin:
10. Have a serum calcitonin ≥20 pg/mL at screening.
11. Kidney Function:
12. Have an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
13. Psychiatric Medications:
14. Are currently taking any psychiatric medications (including, but not limited to depression, anxiety, bipolar disease, attention deficit hyperactivity disorder [ADHD], and schizophrenia).
15. Have doses of these medications not been stable (10%) for at least 3 months prior to screening.
16. Have an intention to change or add new medications during the trial.
17. Weight Loss Medications:
18. Have used any prescription weight loss medication(s) within 30 days of screening or intend to use chronically during the clinical trial.
19. Pregnancy or Breastfeeding:
20. Are pregnant or plan to become pregnant during the study.
21. Are breastfeeding.
22. Other:
23. Are investigator site personnel directly affiliated with this study or their immediate families.
24. Are Lilly employees or employees of third-party organizations (TPOs) involved in the study.
25. Have participated within the last 30 days in a 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.
26. Have previously completed or withdrawn from this study or any other study investigating dulaglutide.
27. Have a hemoglobinopathy or other disorder that interferes with the accurate determination of the primary endpoint.
28. Have a history of severe or serious allergic reaction to study drug or other serious safety concerns.
29. Important Notes:
30. This is a summary of the amended eligibility criteria based on the provided text.
31. The full protocol should be consulted for complete and accurate information.
32. The specific inclusion and exclusion criteria may vary depending on the version of the protocol.
33. Always consult the most up-to-date version of the protocol for the most accurate information.