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

PegBio Co., Ltd.1 site in 1 country546 target enrollmentMay 30, 2022

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

May 30, 2022

End Date

October 31, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PegBio Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following inclusion criteria to be eligible for this study:
•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:
•HbA1c ≥ 7.5% and ≤ 11.0% at screening (local laboratory); HbA1c ≥ 7.0% and ≤ 10.5% (central laboratory) prior to randomization(V3);
•Fasting plasma glucose (FPG) must meet the following criteria:
•FPG \< 15 mmol/l at screening (local laboratory); FPG \< 15 mmol/l (central laboratory) prior to randomization (V3);
•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 cannot be randomized if they meet any of the following 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;
•Patients who develop any of the following heart diseases within six months before screening or prior to randomization:

Arms & Interventions

Test arm

Double-blinded treatment period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage Open-label extended period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage

Intervention: PB-201

Test arm

Double-blinded treatment period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage Open-label extended period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage

Intervention: Metformin hydrochloride

Placebo arm

Double-blinded treatment period: PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively;Basic treatment with stable dose of Glucophage Open-label extended period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage

Intervention: PB-201 matched placebo

Placebo arm

Double-blinded treatment period: PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively;Basic treatment with stable dose of Glucophage Open-label extended period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage

Intervention: Metformin hydrochloride