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Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

PB-119 75ug

PB-119 150ug

PB-119 200ug

placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and/or females between the ages of ≥18 and ≤70 years at Screening
Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria
HbA1c ≥7.5% and ≤11% at Screening and at Week -1
Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening

Exclusion Criteria:

Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial
Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness
Calcitonin ≥50 ng/L at screening
Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2
Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening
Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial
Blood amylase or lipase >3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening
Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 at Screening
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) at Screening and pre-randomization
Severe cardiovascular diseases occurring within 6 months prior to screening

Sites / Locations

Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

PB-119 75ug

PB-119 150ug

PB-119 200ug

placebo

Arm Description

PB-119 injection 75ug subcutaneously injected once-weekly for 12 weeks

PB-119 injection 150ug subcutaneously injected once-weekly for 12 weeks

PB-119 injection 200ug subcutaneously injected once-weekly for 12 weeks

placebo injection subcutaneously injected once-weekly for 12 weeks

Outcomes

Primary Outcome Measures

Change of glycosylated hemoglobin(HbA1c)

Change of HbA1c from baseline value to end of treatment

Secondary Outcome Measures

Percentage of patients achieving HbA1c <7%

Percentage of patients achieving HbA1c <7% at Week 12

Percentage of patients achieving HbA1c ≤6.5%

Percentage of patients achieving HbA1c ≤6.5% at Week 12

HbA1c

Changes of HbA1c from baseline value at Weeks 2, 4, and 8

Fasting plasma glucose(FPG)

Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12.

2-hour postprandial glucose(2-h PPG)

Changes of 2-hour postprandial glucose(2-h PPG) from baseline value at Weeks 4, 8, and 12.

Insulin

Changes of insulin from baseline value at Weeks 4, 8, and 12

C-peptide

Changes of C-peptide from baseline value at Weeks 4, 8, and 12

Self-monitoring of blood glucose (SMBG)

Changes of mean profile and mean increments from baseline value of the 7-point SMBG

Full Information

NCT ID

NCT03520972

First Posted

April 18, 2018

Last Updated

January 21, 2020

Sponsor

PegBio Co., Ltd.

Collaborators

Tigermed Consulting Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03520972

Brief Title

Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects

Official Title

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 in Drug-naïve Subjects With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

June 5, 2018 (Actual)

Primary Completion Date

July 29, 2019 (Actual)

Study Completion Date

July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PegBio Co., Ltd.

Collaborators

Tigermed Consulting Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.

Detailed Description

Subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. The eligible patients will be randomized to 1 of 3 dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

251 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PB-119 75ug

Arm Type

Experimental

Arm Description

PB-119 injection 75ug subcutaneously injected once-weekly for 12 weeks

Arm Title

PB-119 150ug

Arm Type

Experimental

Arm Description

PB-119 injection 150ug subcutaneously injected once-weekly for 12 weeks

Arm Title

PB-119 200ug

Arm Type

Experimental

Arm Description

PB-119 injection 200ug subcutaneously injected once-weekly for 12 weeks

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo injection subcutaneously injected once-weekly for 12 weeks

Intervention Type

Drug

Intervention Name(s)

PB-119 75ug

Intervention Description

60 eligible patients will be included in this group

Intervention Type

Drug

Intervention Name(s)

PB-119 150ug

Intervention Description

60 eligible patients will be included in this group

Intervention Type

Drug

Intervention Name(s)

PB-119 200ug

Intervention Description

60 eligible patients will be included in this group

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

60 eligible patients will be included in this group

Primary Outcome Measure Information:

Title

Change of glycosylated hemoglobin(HbA1c)

Description

Change of HbA1c from baseline value to end of treatment

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Percentage of patients achieving HbA1c <7%

Description

Percentage of patients achieving HbA1c <7% at Week 12

Time Frame

12 weeks

Title

Percentage of patients achieving HbA1c ≤6.5%

Description

Percentage of patients achieving HbA1c ≤6.5% at Week 12

Time Frame

12 weeks

Title

HbA1c

Description

Changes of HbA1c from baseline value at Weeks 2, 4, and 8

Time Frame

2, 4, and 8 weeks

Title

Fasting plasma glucose(FPG)

Description

Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12.

Time Frame

2, 4, 8, and 12 weeks

Title

2-hour postprandial glucose(2-h PPG)

Description

Changes of 2-hour postprandial glucose(2-h PPG) from baseline value at Weeks 4, 8, and 12.

Time Frame

4, 8, and 12 weeks

Title

Insulin

Description

Changes of insulin from baseline value at Weeks 4, 8, and 12

Time Frame

4, 8, and 12 weeks

Title

C-peptide

Description

Changes of C-peptide from baseline value at Weeks 4, 8, and 12

Time Frame

4, 8, and 12 weeks

Title

Self-monitoring of blood glucose (SMBG)

Description

Changes of mean profile and mean increments from baseline value of the 7-point SMBG

Time Frame

4, 8, and 12 weeks

Other Pre-specified Outcome Measures:

Title

Body mass index(BMI)

Description

Changes of BMI from baseline value at Weeks 2, 4, 8, and 12.

Time Frame

2, 4, 8, and 12 weeks

Title

Waist and hip circumferences and waist-to-hip ratio

Description

Change of waist and hip circumferences and waist-to-hip ratio from baseline value at end of treatment(waist and hip circumferences will be used to calculate waist-to-hip ratio

Time Frame

12 weeks

Title

Blood pressure(both systolic and diastolic)

Description

Changes of blood pressure from baseline value at Weeks 2, 4, 8, and 12.

Time Frame

2, 4, 8, and 12 weeks

Title

Blood lipid

Description

Changes of blood lipid from baseline value at Weeks 2, 4, 8, and 12

Time Frame

2, 4, 8, and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and/or females between the ages of ≥18 and ≤70 years at Screening Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria HbA1c ≥7.5% and ≤11% at Screening and at Week -1 Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening Exclusion Criteria: Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness Calcitonin ≥50 ng/L at screening Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2 Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial Blood amylase or lipase >3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 at Screening Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) at Screening and pre-randomization Severe cardiovascular diseases occurring within 6 months prior to screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linong Ji, MD,PhD

Organizational Affiliation

Peking University People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University People's Hospital

City

Peking

ZIP/Postal Code

100000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

33687487

Citation

Ji L, Du Y, Xu M, Zhou X, Mo Z, Ma J, Li J, Li Y, Lin J, Wang Y, Yang J, Song W, Jin H, Pang S, Liu H, Li P, Liu J, Yao M, Li W, Jiang X, Shen F, Geng H, Zhou H, Ran J, Lei M, Du Y, Ye S, Guan Q, Lv W, Tan H, Chen T, Yang J, Qin G, Li S, Chen L. Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study. Diabetologia. 2021 May;64(5):1066-1078. doi: 10.1007/s00125-021-05392-9. Epub 2021 Mar 9. Erratum In: Diabetologia. 2021 Aug;64(8):1900-1901.

Results Reference

derived

PubMed Identifier

30957581

Citation

Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

Results Reference

derived

Learn more about this trial

Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects

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