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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01658501
First received: July 24, 2012
Last updated: November 5, 2015
Last verified: November 2015
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: 50 mg PB1023
Drug: 70 mg PB1023
Drug: 100 mg PB1023
Drug: Placebo (0.9% Sodium Chloride)
Drug: Victoza®
Other: Diet and Exercise
Drug: Metformin
Drug: Sulfonylurea
Drug: Metformin and Sulfonylurea
Phase 2

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

Resource links provided by NLM:


Further study details as provided by PhaseBio Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Description of the incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator [ Time Frame: Up to 23 weeks ] [ Designated as safety issue: Yes ]
  • Compare change from baseline in weekly fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator [ Time Frame: Baseline and 20 weeks ] [ Designated as safety issue: No ]
  • Describe the frequencies of adverse events in the treatment groups [ Time Frame: Up to 23 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing [ Time Frame: Baseline and 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 593
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet and Exercise
Diet and exercise only.
Drug: 50 mg PB1023 Drug: 70 mg PB1023 Drug: 100 mg PB1023 Drug: Placebo (0.9% Sodium Chloride)
Other Name: SC Weekly Injection
Drug: Victoza®
Other Name: daily SC injection
Experimental: Metformin
Metformin only
Drug: 50 mg PB1023 Drug: 70 mg PB1023 Drug: 100 mg PB1023 Drug: Placebo (0.9% Sodium Chloride)
Other Name: SC Weekly Injection
Drug: Victoza®
Other Name: daily SC injection
Experimental: Sulfonylurea
Sulfonylurea only
Drug: 50 mg PB1023 Drug: 70 mg PB1023 Drug: 100 mg PB1023 Drug: Placebo (0.9% Sodium Chloride)
Other Name: SC Weekly Injection
Drug: Victoza®
Other Name: daily SC injection
Experimental: Metformin and Sulfonylurea
Metformin and Sulfonylurea combination therapy
Drug: 50 mg PB1023 Drug: 70 mg PB1023 Drug: 100 mg PB1023 Drug: Placebo (0.9% Sodium Chloride)
Other Name: SC Weekly Injection
Drug: Victoza®
Other Name: daily SC injection
Experimental: PB1023
PB1023 weekly SC injection
Drug: 50 mg PB1023 Drug: 70 mg PB1023 Drug: 100 mg PB1023 Other: Diet and Exercise Drug: Metformin Drug: Sulfonylurea Drug: Metformin and Sulfonylurea
Placebo Comparator: Placebo Comparator
Placebo (0.9% Sodium Chloride) weekly SC injection
Drug: Placebo (0.9% Sodium Chloride)
Other Name: SC Weekly Injection
Other: Diet and Exercise Drug: Metformin Drug: Sulfonylurea Drug: Metformin and Sulfonylurea
Active Comparator: Active Comparator
Active Comparator (Victoza) daily SC injection
Drug: Victoza®
Other Name: daily SC injection
Other: Diet and Exercise Drug: Metformin Drug: Sulfonylurea Drug: Metformin and Sulfonylurea

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658501

  Show 93 Study Locations
Sponsors and Collaborators
PhaseBio Pharmaceuticals Inc.
  More Information

Responsible Party: PhaseBio Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01658501     History of Changes
Other Study ID Numbers: PB1023-PT-CL-0004 
Study First Received: July 24, 2012
Last Updated: November 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 21, 2016