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

Sponsor

PegBio Co., Ltd. (Other)

Overall Status

Recruiting

CT.gov ID

NCT05102149

Collaborator

(none)

672

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus (T2DM)	Drug: PB-201 Drug: Vildagliptin Drug: PB-201 matched placebo Drug: Vildagliptin matched placebo	Phase 3

Detailed Description

The study consists of a screening period of up to 2 weeks, a 4-week single-blind run-in period, a 24-week double-blinded treatment period, a 28-week extended treatment period, and a 2-week safety follow-up period.Eligible subjects will be enrolled in a 4-week single-blind run-in period with daily oral administration of 1 tablet of PB-201 matched placebo and 1 Vildagliptin matched placebo in the morning and evening respectively.After the end of the single-blind run-in period, subjects who meet the protocol enrollment requirements will be randomized in the proportion of 2:1:1 to receive double-blinded treatment for 24 weeks in three different treatment groups (test arm, Vildagliptin arm, or placebo arm).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

672 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test arm 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-201 PB-201: 100 mg each time, orally in the morning and evening respectively; Drug: Vildagliptin matched placebo One tablet each time, orally in the morning and evening respectively;
Active Comparator: Vildagliptin arm 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: Vildagliptin Vildagliptin: 50 mg each time, orally in the morning and evening respectively; Drug: PB-201 matched placebo PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively;
Placebo Comparator: Placebo arm 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 placebo PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively; Drug: Vildagliptin matched placebo One tablet each time, orally in the morning and evening respectively;

Arm

Intervention/Treatment

Experimental: Test arm

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-201

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

Drug: Vildagliptin matched placebo

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

Active Comparator: Vildagliptin arm

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: Vildagliptin

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

Drug: PB-201 matched placebo

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

Placebo Comparator: Placebo arm

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 placebo

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

Drug: Vildagliptin matched placebo

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;
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.

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);
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;
Hepatitis B surface antigen is positive, and the result of hepatitis B virus DNA quantitative test is higher than the lower limit of the test reference range (Note: If the local laboratory cannot carry out quantitative detection of hepatitis B virus, the sample will be sent to the central laboratory.);

Patients who have any disease at screening or prior to randomization that may cause hemolysis or red blood cell instability affecting HbA1c testing, such as hemolytic anemia;
Subject who has participated in any drug or medical device clinical study within three months before screening or prior to randomization (except those who fail in screening or do not receive any trial drug);
Patients who have a prior history of clearly diagnosed psychiatric disorders, unwilling or unable to fully understand and cooperate, or assessed by the investigator as unsuitable for participation in this clinical study;
Patients who have a prior history of drinking [(>2 units of alcohol per day and >14 units of alcohol per week (one unit of alcohol corresponds to 150mL of grape wine or 350mL of beer or 50 mL of spirits)] or history of drug abuse;
Patients who are known to be allergic or intolerant to the test drug or Vildagliptin or their excipients, or who have contraindications;
Patients who have refractory urinary or genital infections within six months before screening, or are known to be allergic to Empagliflozin or its excipients;
Female in pregnancy or lactation period;
Partners of male subjects or female subjects who plan to become pregnant or who are unable or unwilling to use contraceptive methods required by the protocol from the signing of the informed consent form to 30 days after the last dose of the drug;
The investigator judges that the subject is unable to comply with the protocol requirements, such as unable to adhere to diet and exercise treatment during the study, unable to take drugs and meals on time according to the protocol requirements, and unable to conduct self-monitoring of blood glucose (SMBG) in time and record;
Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this clinical study.

Contacts and Locations

Locations

	Site	City	State	Country
1	The Second People's Hospital of Hefei	Hefei	Anhui	China
2	Lu'an People's Hospital	Lu'an	Anhui	China
3	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China
4	Beijing Pinggu Hospital	Beijing	Beijing	China
5	Beijing Tsinghua Changgung Hospital	Beijing	Beijing	China
6	Peking Union Medical College Hospital	Beijing	Beijing	China
7	Peking University First Hospital	Beijing	Beijing	China
8	Peking University People's Hospital	Beijing	Beijing	China
9	Chongqing University Three Gorges Hospital	Chongqing	Chongqing	China
10	Lanzhou University Second Hospital	Lanzhou	Gansu	China
11	Huizhou Municipal Central Hospital	Huizhou	Guangdong	China
12	Cangzhou People's Hospital	Cangzhou	Hebei	China
13	Handan First Hospital	Handan	Hebei	China
14	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang	China
15	The First Hospital of Qiqihar	Qiqihar	Heilongjiang	China
16	Huaihe Hospital of Henan University	Kai Feng	Henan	China
17	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan	China
18	Shiyan Renmin Hospital	Shiyan	Hubei	China
19	The Third Hospital of Changsha	Changsha	Hunan	China
20	Chenzhou No.1 People's Hospital	Chenzhou	Hunan	China
21	Inner Mongolia Baogang Hospital	Baotou	Inner Mongolia	China
22	Nanjing First Hospital	Nanjing	Jiangsu	China
23	Nanjing Jiangning Hospital	Nanjing	Jiangsu	China
24	Sir Run Run Hospital Nanjing Medical Universtiy	Nanjing	Jiangsu	China
25	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China
26	Affiliated Hospital of Nantong University	Nantong	Jiangsu	China
27	Nantong First People's Hospital	Nantong	Jiangsu	China
28	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi	China
29	The Second Hospital of Jilin University	Changchun	Jilin	China
30	Panjin LiaoHe Oil Field Gem Flower Hospital	Panjin	Liaoning	China
31	Tangdu Hospital, Air Force Medical University	Xi'an	Shaanxi	China
32	Jinan Central Hospital	Jinan	Shandong	China
33	Qingdao Central Hospital	Qingdao	Shandong	China
34	Peace Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi	China
35	The Third People's Hospital of Datong	Datong	Shanxi	China
36	Yan'an University Affiliated Hospital	Ya'an	Shanxi	China
37	Chengdu Fifth People's Hospital	Chengdu	Sichuan	China
38	Huzhou Central Hospital	Huzhou	Zhejiang	China
39	Jiaxing Second Hospital	Jiaxing	Zhejiang	China
40	The Chinese University of Hong Kong, Prince of Wales Hospital	Hong Kong		Hong Kong
41	The University of Hong Kong, Queen Mary Hospital	Hong Kong		Hong Kong
42	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

PegBio Co., Ltd.

Investigators

Principal Investigator: Linong Ji, MD,PhD, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PegBio Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05102149

Other Study ID Numbers:

PB201303

First Posted:

Nov 1, 2021

Last Update Posted:

Feb 8, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Vildagliptin

Study Results

No Results Posted as of Feb 8, 2022