Clinical trial NCT04504370: Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects
Official title: A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: PegBio Co., Ltd.
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 follow-up period.

At the end of the single-blind entry period, eligible subjects were randomly assigned to two different administration groups in a 1:1 ratio and received a 24-week double-blind treatment.

All subjects who completed the double-blind treatment entered the open extension treatment phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28 weeks.

Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit visit in the open extension period.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18\~75 years old;
* Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999；
* 18.5 kg/m2 \< BMI \< 40.0 kg/m2 at screening;
* 7.5% ≤ HbA1c ≤ 11.0% at screening;
* 7.0% ≤ HbA1c ≤ 10.5% when the random;
* 18.5 kg/m2 \< BMI \< 40.0 kg/m2 during screening and before randomization

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: week 1, week 25
Secondary outcomes:
measure: HbA1c Below 7.0%
timeFrame: week 1, week 25
measure: Change in Body Weight (kg)
timeFrame: week 1, week 25
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: week 1, week 25
measure: Change in Body Mass Index
timeFrame: week 1, week 25
Other outcomes:
Locations:
city: Changsha
country: China
facility: Central South University The Second Xiangya Hospital
state: Hunan
Study officials:
affiliation: Central South University The Second Xiangya Hospital
name: Zhiguang Zhou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital of Chenzhou
name: WeiHong Song, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Shanxi Medical University
name: Jing Yang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tang-Du Hospital
name: Bin Gao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Qianfoshan Hospital
name: Lin Liao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Hospital of Jilin University
name: YanJun Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Qingdao Central Hospital
name: Minxiu Yao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changsha Central Hospital
name: Huige Shao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin People's Hospital
name: Jingna Lin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cangzhou Central Hospital
name: Jiarui Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ZhuZhou Central Hospital
name: Xiaohong Lin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Guixia Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jianhua Ma, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Qiqihar First Hospital
name: Zhinong Zhang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: