Clinical trial NCT04504396: Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of PB-119 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone
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: 620
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: This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy.

Detailed description: This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2 week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119 or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will subsequently be given active drug and patients in placebo group will take placebo, all patients in two groups will remain metformin background therapy. In the 28-week open-label period, all patients will be administered active drugs. After that, there will be a 4-week follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic (PK) analysis.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18\~75 years old;
* T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,\<1500mg) constantly for at least 8 consecutive weeks;
* 7.5% ≤ HbA1c ≤ 10.0% at screening;
* 18.5 kg/m2 \< BMI \< 40.0 kg/m2 at screening;

Exclusion Criteria:

* Any anti-diabetic therapy other than Metformin within 8 weeks before screening；
* T1DM;
* Received insulin therapy more than 14 days within 1 year before screening;
* Female who is pregnant, breast-feeding;
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol;
* History of acute diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar status within 6 months before screening；
* History or presence of pancreatitis (acute or chronic);
* Presence or history of malignant neoplasms within the past 5 years prior to the day of screening

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: Beijing
country: China
facility: Beijing University People's Hospital
state: Beijing
Study officials:
affiliation: First Hospital of Hebei Medical University
name: HuiMin Zhou, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital of Chenzhou
name: WeiHong Song, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Hospital of Jilin University
name: YanJun Wang, 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: People's Hospital of Xinjiang Uygur Autonomous Region
name: XinLing Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Hebei University
name: MingHui Hou, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Qianfoshan Hospital
name: Lin Liao, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing University People's Hospital
name: Linong Ji, 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: ZhuZhou Central Hospital
name: Xiaohong Lin, 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: Wei Zhang, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Luoyang Central Hospital
name: Hui Liu, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baotou Central Hospital
name: Tao Ning, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Province People's Hospital
name: Xiaohong Wu, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jingzhou Central Hospital
name: Xueying Wang, MD，PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: WuXi Central Hospital
name: Lan Xu, MD，PhD
role: PRINCIPAL_INVESTIGATOR
References: