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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520972
• Other study ID #: PB119201
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2018
• Est. completion date: July 29, 2019

Study information

• Verified date: January 2020
• Source: PegBio Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: July 29, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Males and/or females between the ages of =18 and =70 years at Screening

2. Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria

3. HbA1c =7.5% and =11% at Screening and at Week -1

4. Body mass index (BMI) =18.5 and =35.0 kg/m2 at Screening

Exclusion Criteria:

1. 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

2. 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

3. Calcitonin =50 ng/L at screening

4. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2

5. 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

6. 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

7. Blood amylase or lipase >3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening

8. 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

9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) at Screening and pre-randomization

10. Severe cardiovascular diseases occurring within 6 months prior to screening

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• PB-119 75ug
60 eligible patients will be included in this group
• PB-119 150ug
60 eligible patients will be included in this group
• PB-119 200ug
60 eligible patients will be included in this group
• placebo
60 eligible patients will be included in this group

Locations

Country	Name	City	State
China	Peking University People's Hospital	Peking

Sponsors (2)

Lead Sponsor	Collaborator
PegBio Co., Ltd.	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index(BMI)	Changes of BMI from baseline value at Weeks 2, 4, 8, and 12.	2, 4, 8, and 12 weeks
Other	Waist and hip circumferences and waist-to-hip ratio	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	12 weeks
Other	Blood pressure(both systolic and diastolic)	Changes of blood pressure from baseline value at Weeks 2, 4, 8, and 12.	2, 4, 8, and 12 weeks
Other	Blood lipid	Changes of blood lipid from baseline value at Weeks 2, 4, 8, and 12	2, 4, 8, and 12 weeks
Primary	Change of glycosylated hemoglobin(HbA1c)	Change of HbA1c from baseline value to end of treatment	12 weeks
Secondary	Percentage of patients achieving HbA1c <7%	Percentage of patients achieving HbA1c <7% at Week 12	12 weeks
Secondary	Percentage of patients achieving HbA1c =6.5%	Percentage of patients achieving HbA1c =6.5% at Week 12	12 weeks
Secondary	HbA1c	Changes of HbA1c from baseline value at Weeks 2, 4, and 8	2, 4, and 8 weeks
Secondary	Fasting plasma glucose(FPG)	Changes of fasting plasma glucose(FPG) from baseline value at Weeks 2, 4, 8, and 12.	2, 4, 8, and 12 weeks
Secondary	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.	4, 8, and 12 weeks
Secondary	Insulin	Changes of insulin from baseline value at Weeks 4, 8, and 12	4, 8, and 12 weeks
Secondary	C-peptide	Changes of C-peptide from baseline value at Weeks 4, 8, and 12	4, 8, and 12 weeks
Secondary	Self-monitoring of blood glucose (SMBG)	Changes of mean profile and mean increments from baseline value of the 7-point SMBG	4, 8, and 12 weeks