Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy

NCT05326490 | Unknown Phase 3

• 1 other identifier: PB201302
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change of glycosylated hemoglobin (HbA1c) from baseline to 24 weeks after treatment

  Week 1,Week 25

Study Arms (2)

Test arm

EXPERIMENTAL

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

Drug: PB-201; Drug: Metformin hydrochloride

Placebo arm

PLACEBO COMPARATOR

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

Drug: PB-201 matched placebo; Drug: Metformin hydrochloride

Interventions

PB-201 DRUG

PB-201: 100 mg each time, orally in the morning and evening respectively

Test arm

PB-201 matched placebo DRUG

PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively

Placebo arm

Metformin hydrochloride DRUG

The dosage and administration of metformin hydrochloride remain unchanged before screening

Placebo arm; Test arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Decompensated cardiac insufficiency (New York Heart Association NYHA Classification of grade III or IV); Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, or coronary artery balloon dilates or coronary stent implantation; Severe arrhythmias (e.g., second- or third-degree atrioventricular block, long QT syndrome, or QTcF \> 480 ms); Arrhythmias that require treatment, or other arrhythmias assessed by the investigator as unsuitable for participation in this clinical study;
• Patients whose hypertension symptoms are not effectively controlled at screening or prior to randomization (sitting systolic blood pressure ≥160mmHg and/or sitting diastolic blood pressure ≥ 100mmHg after resting ≥5 minutes);
• Patients who have hemorrhagic stroke or acute ischemic stroke within six months before screening or prior to randomization;
• Patients who have severe kidney disease or estimated glomerular filtration rate eGFR \< 60mL/(min 1.73 m2) or in routine urine qualitative proteinuria ≥ (++) or quantitative proteinuria ≥1 g/L at screening or prior to randomization;
• Patients who have a history of acute or chronic pancreatitis at screening or prior to randomization;

Sponsors & Collaborators

• PegBio Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Lead-201; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Ying Du, MD,PhD

CONTACT

+8618911797119; ying.du@pegbio.com

Michael Xu, MD,PhD

CONTACT

+8651262956129; michael.xu@pegbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: May 30, 2022
• Primary Completion: September 24, 2024
• Study Completion: October 31, 2024
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)