Status:
COMPLETED
Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects
Lead Sponsor:
PegBio Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.
Detailed Description
The study included a maximum 2-week screening period, a 4-week single-blind introduction period, a 24-week double-blind treatment period, a 28-week open extension treatment period, and a 4-week safety...
Eligibility Criteria
Inclusion
- Male or female, aged 18\~75 years old;
- Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999；
- 5 kg/m2 \< BMI \< 40.0 kg/m2 at screening;
- 5% ≤ HbA1c ≤ 11.0% at screening;
- 0% ≤ HbA1c ≤ 10.5% when the random;
- 5 kg/m2 \< BMI \< 40.0 kg/m2 during screening and before randomization
Exclusion
- T1DM;
- Continuous use of insulin for more than 14 days within 1 year before screening or before randomization；
- Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependent insulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist prior to screening or randomized prior treatment；
- Screening for any of the following heart diseases within the first 6 months or before randomization；
- Patients whose hypertension was not effectively controlled during screening or before randomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
- Serum amylase or lipase \>3×ULN or those with previous diagnosis of acute/chronic pancreatitis were screened or randomly screened；
- Screening for severe trauma or infection that may affect glycemic control within the first month or before randomization；
- A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)；
- Known to be allergic or intolerant to the study drug or metformin；
- Female subjects during pregnancy or lactation.
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2022
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT04504370
Start Date
April 27 2020
End Date
November 28 2022
Last Update
July 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Central South University The Second Xiangya Hospital
Changsha, Hunan, China