Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy

  • STATUS
    Recruiting
  • End date
    Apr 29, 2023
  • participants needed
    600
  • sponsor
    PegBio Co., Ltd.
Updated on 28 October 2021
metformin
glucagon
hemoglobin a1c

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.

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.

Details
Condition Diabetes (Pediatric), Diabetes Mellitus, diabetes type 2, noninsulin-dependent diabetes mellitus, Diabetes Mellitus, Type 2, NIDDM, type 2 diabetes mellitus, Diabetes Mellitus Type 2, type 2 diabetes, Diabetes Prevention, type ii diabetes, Diabetes Mellitus Types I and II
Treatment Placebo, GLP-1 receptor agonist
Clinical Study IdentifierNCT04504396
SponsorPegBio Co., Ltd.
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

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
5% HbA1c 10.0% at screening
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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