Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Type 2 Diabetes
• Age: Between 10 Year(s) - 17 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. 10 to 17 years of age, inclusive, at the time of signing the informed consent and assent.
  2. have a diagnosis of T2DM according to the World Health Organization criteria at least 3 months before enrollment.
  3. have an HbA1c level of 6.5% to 9.5%, inclusive, at screening.
  4. are insulin-naïve or have been without insulin treatment for at least 3 months prior to screening.
  Note: participants may be treated with a stable dose of metformin, either alone or in combination with a stable dose of a SGLT2 inhibitor, for at least 3 months prior to screening and are willing to continue stable use throughout the study.
  
  Note: all oral antihyperglycemic medications must be used in accordance with the corresponding local product label at the time of screening.
  5. are capable of giving signed informed consent or assent, or the legally authorized representative is capable of giving informed consent.
  6. are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.
  7. have venous access sufficient to allow blood sampling as per the protocol

  
  

You may not be eligible for this study if the following are true:

• 1. have a diagnosis of T1DM, or specific type of diabetes other than T2DM, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.
  2. have a history of 1 or more episodes of ketoacidosis, hyperosmolar state, or coma requiring hospitalization within 6 months prior to screening.
  3. have had a severe hypoglycemia episode within 6 months prior to screening.
  4. have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate less than 30 mL/min/1.73 m2, as determined at screening.
  5. have had a blood transfusion or severe blood loss within 90 days prior to screening.
  6. have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
  7. have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy within 5 years prior to screening.
  8. are at increased risk for developing cancer or a recurrence of cancer.
  9. have a history of or current significant psychiatric disorders
  10. are receiving or received systemic glucocorticoid therapy for more than 14 days within 30 days prior to screening. Exceptions are:
      • replacement therapy for adrenal insufficiency
      • topical, intraocular, intranasal, or inhaled preparations