NCT05102149|UnknownPhase 3

Study to Evaluate the Safety and Efficacy of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus

A Multi-center, Randomized, Double-Blinded, Parallel, Vildagliptin and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus

PegBio Co., Ltd.ClinicalTrials.gov

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1 other identifier

PB201303

Study Type

interventional

Target

672

Locations

3 countries

Sites

Timeline

RegisteredNov 2021

StartedSep 2021

CompletionApr 2025

Brief Summary

This is a multicenter, randomized, double-blind, parallel, Vildagliptin and Placebo-Controlled study to evaluate the efficacy and safety of oral administration of 100 mg of PB-201 in the morning and evening in treatmentnaive patients with type 2 diabetes mellitus.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

672

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Sep 2021

Typical duration for phase_3

Geographic Reach

3 countries

42 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

Study Start

First participant enrolled

September 30, 2021

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed

12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed

Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

October 20, 2021

Last Update Submit

February 7, 2022

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change from baseline in HbA1c after 24 weeks of treatment
Week 1,Week 25

Study Arms (3)

Test arm

EXPERIMENTAL

PB-201: 100 mg each time, orally in the morning and evening respectively; Vildagliptin matched placebo: One tablet each time, orally in the morning and evening respectively;

Drug: PB-201Drug: Vildagliptin matched placebo

Vildagliptin arm

ACTIVE COMPARATOR

Vildagliptin: 50 mg each time, orally in the morning and evening respectively; PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively;

Drug: VildagliptinDrug: PB-201 matched placebo

Placebo arm

PLACEBO COMPARATOR

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

Drug: PB-201 matched placeboDrug: Vildagliptin matched placebo

Interventions

PB-201DRUG

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

Test arm

VildagliptinDRUG

Vildagliptin: 50 mg each time, orally in the morning and evening respectively;

Vildagliptin arm

PB-201 matched placeboDRUG

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

Placebo armVildagliptin arm

Vildagliptin matched placeboDRUG

One tablet each time, orally in the morning and evening respectively;

Placebo armTest arm

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males or females aged ≥18 years and ≤ 75 years at screening;
Diagnosed T2DM patients who meet the diagnostic criteria for type 2 diabetes mellitus issued by WHO in 1999 (see Appendix 2 for diagnostic criteria of type 2 diabetes mellitus);
Receive diet and exercise interventions for at least eight weeks before screening and do not receive any anti-diabetes medications within eight weeks before screening;
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);
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);
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 six months before screening, or who have had severe hypoglycemia prior to randomization since screening ;
Patients who have hemorrhagic stroke or acute ischemic stroke within six months before screening or prior to randomization;
Patients who have a history of acute or chronic pancreatitis at screening or prior to randomization;
Patients who suffer from any serious gastrointestinal diseases (such as gastroparesis, inflammatory bowel disease, intestinal obstruction) that affect drug absorption within six months before screening or prior to randomization, or have underwent gastrointestinal operations that affect drug absorption (such as gastrectomy, gastroenterostomy or enterectomy, etc.);
Patients who have severe trauma or serious infection that may affect glycaemic control within one month before screening or prior to randomization, such as bone fracture, pneumonia, etc.;
Patients with any type of treated or untreated malignancy (whether cured or not) within five years before screening or prior to randomization. However, patients with cured basal cell carcinoma of the skin do not need to be excluded;
Patients with thyroid dysfunction not controlled by stable drug dosage at screening or abnormalities of thyroid function test with clinically significant at screening and requiring medical treatment;
Patients who have any of the following laboratory abnormalities at screening:
Human immunodeficiency virus antibody or Treponema pallidum specific antibody positive;
Hepatitis C antibody positive;
+11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

PegBio Co., Ltd.lead

Study Sites (42)

The Second People's Hospital of Hefei

Hefei, Anhui, China

NOT YET RECRUITING

Lu'an People's Hospital

Lu'an, Anhui, China

NOT YET RECRUITING

Beijing Friendship Hospital, Capital Medical University