Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 10813 for:    Placebo AND once

Dose-finding of PB-119 Administered Subcutaneously Once Weekly Versus Placebo in Subjects With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03604419
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
PegBio Co., Ltd.

Brief Summary:
A phase 2, multicenter study to evaluate the efficacy and safety of twelve once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin mono therapy.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Drug: PB-119 100 μg+ Glucophage® Drug: PB-119 150 μg+ Glucophage® Drug: PB-119 200 μg+ Glucophage® Drug: PB-119 placebo + Glucophage® Phase 2

Detailed Description:
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 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 and a 12-week double-blind treatment period.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 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin monotherapy 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 1) active drug or placebo at a 3:1 active drug:placebo ratio and 2) exclusion from or inclusion in the pharmacokinetic (PK) blood sample collection subgroup at a 3:1 excluded:included ratio

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 to Patients With Type 2 Diabetes Mellitus (T2DM) Not Well-controlled by Metformin Monotherapy
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arm Intervention/treatment
Experimental: PB-119 100 μg
PB-119 100 μg subcutaneous (SC) once weekly (QW) + Metformin oral (p.o.) Glucophage® (stable dosage)
Drug: PB-119 150 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Drug: PB-119 200 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Drug: PB-119 placebo + Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Experimental: PB-119 150 μg
PB-119 150 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
Drug: PB-119 100 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Drug: PB-119 200 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Drug: PB-119 placebo + Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Experimental: PB-119 200 μg
PB-119 200 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
Drug: PB-119 100 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Drug: PB-119 150 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Drug: PB-119 placebo + Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Placebo Comparator: PB-119 Placebo
PB-119 Placebo SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)
Drug: PB-119 100 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Drug: PB-119 150 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Drug: PB-119 200 μg+ Glucophage®
Each patient will subsequently be randomized within the designated cohort to active drug or placebo




Primary Outcome Measures :
  1. The change from baseline value of HbA1c will be compared between treatments [ Time Frame: From Baseline to end of treatment (up to Week 12) ]

Secondary Outcome Measures :
  1. The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12 [ Time Frame: From Baseline to end of treatment (up to Week 12) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients in whom T2DM has been diagnosed according to 2018 American Diabetes Association T2DM diagnostic criteria, have made lifestyle modifications (ie, diet and exercise) for at least 3 months prior to Screening, and have been taking metformin for at least 3 months before Screening with a stable dosage for at least 8 weeks (stable dosage is defined as metformin dosage ≥1500 mg/day or maximum tolerated dose).
  2. Males and/or females between the ages of ≥18 and ≤70 years at Screening
  3. HbA1c ≥7.5% and ≤11% at Screening and at Week -1, Visit 3.1;
  4. FPG ≥126 and ≤240 mg/dL (≥7.0 and ≤13.3 mmol/L) at Screening and at Week -1, Visit 3.1;
  5. Body mass index (BMI) ≥18.5 and ≤40.0 kg/m2 at Screening, with inclusion of patients with BMIs at the lower end of the range enrolled into the study to enable comparisons across BMI range;

Exclusion Criteria:

  1. Medical history or current diagnosis of:

    1. Type 1 diabetes mellitus, diabetes caused by pancreas injury or by other diseases (like acromegaly or Cushing syndrome);
    2. Diabetes acute complication, like ketoacidosis or hyperosmolar coma;
    3. Diagnosed proliferative retinopathy;
    4. 3 instances of severe hypoglycemia (events during which the patient required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions; episodes may be associated with sufficient neuroglycopenia to have induced seizure or coma) in the 6 months prior to Screening;
    5. Significant vascular disease;
  2. Current/ongoing diagnosis of any type of malignant tumor or evidence of recurrence in the 6 months prior to Screening (patients who have been stable for ≥6 months or those who have had basal or squamous cell skin cancers removed and have no evidence of recurrence will not be excluded). Patients with a medical history of any other type of cancer in the last 5 years prior to Screening will be excluded;
  3. Severe cardiovascular diseases occurring within 6 months prior to Screening (eg, congestive heart disease, myocardial infarction, acute coronary syndrome, apoplexy, transient ischemic attack);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604419


Contacts
Layout table for location contacts
Contact: Roman Dvorak, MD,PhD 401 932 2944 ext +1 rd@pegbio.com
Contact: Michael Xu, MD,PhD 62956129 ext 0512 michael.xu@pegbio.com

Locations
Layout table for location information
United States, Florida
Clinical Pharmacology of Miami Recruiting
Miami, Florida, United States, 33014
Contact: KENNETH Lasseter, MD         
Sponsors and Collaborators
PegBio Co., Ltd.
Covance

Layout table for additonal information
Responsible Party: PegBio Co., Ltd.
ClinicalTrials.gov Identifier: NCT03604419     History of Changes
Other Study ID Numbers: PB119202
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs