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

NCT03604419 | Completed Phase 2 FDA Drug

• 1 other identifier: PB119202
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• The change from baseline value of HbA1c will be compared between treatments

  From Baseline to end of treatment (up to Week 12)

Secondary Outcomes (1)

• The change from baseline value of Fasting Plasma Glucose at Weeks 2, 4, 8, and 12

  From Baseline to end of treatment (up to Week 12)

Study Arms (4)

PB-119 100 μg

EXPERIMENTAL

PB-119 100 μg subcutaneous (SC) once weekly (QW) + Metformin oral (p.o.) Glucophage® (stable dosage)

Drug: PB-119 150 μg+ Glucophage®; Drug: PB-119 200 μg+ Glucophage®; Drug: PB-119 placebo + Glucophage®

PB-119 150 μg

EXPERIMENTAL

PB-119 150 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)

Drug: PB-119 100 μg+ Glucophage®; Drug: PB-119 200 μg+ Glucophage®; Drug: PB-119 placebo + Glucophage®

PB-119 200 μg

EXPERIMENTAL

PB-119 200 μg SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)

Drug: PB-119 100 μg+ Glucophage®; Drug: PB-119 150 μg+ Glucophage®; Drug: PB-119 placebo + Glucophage®

PB-119 Placebo

PLACEBO COMPARATOR

PB-119 Placebo SC QW + Metformin oral (p.o.) Glucophage® (stable dosage)

Drug: PB-119 100 μg+ Glucophage®; Drug: PB-119 150 μg+ Glucophage®; Drug: PB-119 200 μg+ Glucophage®

Interventions

PB-119 100 μg+ Glucophage® DRUG

Each patient will subsequently be randomized within the designated cohort to active drug or placebo

PB-119 150 μg; PB-119 200 μg; PB-119 Placebo

PB-119 150 μg+ Glucophage® DRUG

Each patient will subsequently be randomized within the designated cohort to active drug or placebo

PB-119 100 μg; PB-119 200 μg; PB-119 Placebo

PB-119 200 μg+ Glucophage® DRUG

Each patient will subsequently be randomized within the designated cohort to active drug or placebo

PB-119 100 μg; PB-119 150 μg; PB-119 Placebo

PB-119 placebo + Glucophage® DRUG

Each patient will subsequently be randomized within the designated cohort to active drug or placebo

PB-119 100 μg; PB-119 150 μg; PB-119 200 μg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Males and/or females between the ages of ≥18 and ≤70 years at Screening
• HbA1c ≥7.5% and ≤11% at Screening and at Week -1, Visit 3.1;
• FPG ≥126 and ≤240 mg/dL (≥7.0 and ≤13.3 mmol/L) at Screening and at Week -1, Visit 3.1;

You may not qualify if:

• Medical history or current diagnosis of:
• Type 1 diabetes mellitus, diabetes caused by pancreas injury or by other diseases (like acromegaly or Cushing syndrome);
• Diabetes acute complication, like ketoacidosis or hyperosmolar coma;
• Diagnosed proliferative retinopathy;
• 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;
• Significant vascular disease;
• 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;
• Severe cardiovascular diseases occurring within 6 months prior to Screening (eg, congestive heart disease, myocardial infarction, acute coronary syndrome, apoplexy, transient ischemic attack);

Sponsors & Collaborators

• PegBio Co., Ltd.: lead
• Covance: collaborator

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Related Publications (1)

• Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

  PMID: 30957581 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: July 27, 2018
• Study Start: June 13, 2018
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)