Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the Pharmacodynamic Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658501
• Other study ID #: PB1023-PT-CL-0004
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2012
• Last updated: November 5, 2015
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2015
• Source: PhaseBio Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary objective:

The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.

Secondary objectives:

The secondary objectives are to:

• Describe incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator;

• Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo and active comparator;

• Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator;

• Describe the frequencies of adverse events in the treatment groups; and

• Describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male and female subjects 18 to 75 years of age, inclusive;

• Body mass index =45 kg/m2;

• Diagnosed with T2DM with HbA1c of =7.0% and =11.0% and treated with diet and exercise alone, or with stable doses of metformin alone, sulfonylurea alone or metformin and sulfonylurea.

Exclusion Criteria:

• Currently taking or have taken within the last 6 months non-oral antihyperglycemic agents (eg, insulin, Byetta®, Bydureon®, or Victoza). Short-term use of insulin within this period will not be cause for exclusion if insulin was used during the treatment of an acute intercurrent illness;

• Known allergy to or serious adverse effect caused by an approved or investigational glucagon-like peptide-1 (GLP-1) receptor analog/agonist;

• Unstable cardiovascular disease;

• History of weight loss surgery or other gastrointestinal surgical procedures that could possibly interfere with the mechanism of action of GLP-1 receptor agonists;

• Based on contraindications/warnings identified with other GLP-1 receptor agonists, subjects will be excluded if they have: History, symptoms, or signs of pancreatitis or severe gastrointestinal disease (ie, gastroparesis) or Personal or family history of medullary thyroid tumors or history of Multiple Endocrine Neoplasia Syndrome Type 2;

• Clinically significant renal and/or hepatic dysfunction;

• Pregnant or lactating female subjects.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 50 mg PB1023

• 70 mg PB1023

• 100 mg PB1023

• Placebo (0.9% Sodium Chloride)

• Victoza®

Other:
• Diet and Exercise

Drug:
• Metformin

• Sulfonylurea

• Metformin and Sulfonylurea

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PhaseBio Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of dose response of Glymera as measured as the change from baseline in HbA1c after 20 weeks of dosing with Glymera compared to placebo and active comparator		Baseline and 20 weeks	No
Secondary	Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator		Up to 23 weeks	Yes
Secondary	Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator		Baseline and 20 weeks	No
Secondary	Describe the frequencies of adverse events in the treatment groups		Up to 23 weeks	Yes
Secondary	Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing		Baseline and 20 weeks	No