Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poo… (NCT05326490) | Clinical Trial Compass
UnknownPhase 3
Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy
China546 participantsStarted 2022-05-30
Plain-language summary
This is a Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients with Poor Glycemic Control via Metformin Hydrochloride Monotherapy
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males or females aged ≥18 years and ≤ 75 years at screening;
✓. Definitely diagnosed T2DM patients who meet the diagnostic criteria for type 2 diabetes mellitus issued by WHO in 1999;
✓. Receive a stable dose of metformin hydrochloride monotherapy ≥ 8 weeks on the basis of diet and exercise interventions before screening and the dose of metformin hydrochloride is ≥ 1500mg/day or the maximum tolerated dose (\<1500mg/day but ≥ 1000mg/day);
✓. The Glycosylated hemoglobin (HbA1c) must meet the following criteria:
✓. Fasting plasma glucose (FPG) must meet the following criteria:
✓. Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 40.0 kg/m2 at screening or prior to randomization (V3);
✓. Able to understand and willing to sign the written informed consent form (ICF) and follow the protocol.
Exclusion criteria
✕. Patients diagnosed with type 1 diabetes mellitus, diabetes due to pancreatic injury, or special type of diabetes due to other diseases (e.g., acromegaly or Cushing's syndrome);
✕. Fasting C-peptide \< 0.8 ng/mL at screening;
✕. Patients who use other hypoglycemic drugs except metformin, systemic glucocorticoids (except inhalation or topical external use) and growth hormones within eight weeks before screening or prior to randomization;
✕. Patients who use insulin continuously for more than 14 days within six months before screening or prior to randomization (the time of insulin treatment for gestational diabetes mellitus is not within this limit);
✕. Patients who receive other glucokinase activators prior to screening or randomization;
✕. Patients who have acute diabetic complications such as diabetic ketoacidosis, lactic acidosis or hyperglycemia and hyperglycemic hyperosmolar status within six months before screening or prior to randomization;
✕. Patients who have severe chronic diabetic complications (such as proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within six months before screening.
✕. Patients who have two or more episodes of severe hypoglycemia within sixmonths before screening, or who have had severe hypoglycemia prior to randomization since screening;