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 Glymera 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: October 18, 2013
Last verified: July 2013

July 24, 2012
October 18, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01658501 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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 Glymera Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM
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 Glymera Injection Following 20 Weeks of Once-Weekly Subcutaneous Dosing in Adult Subjects With Inadequately Treated Type 2 Diabetes Mellitus

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: 50 mg Glymera
  • Drug: 70 mg Glymera
  • Drug: 100 mg Glymera
  • Drug: Placebo (0.9% Sodium Chloride)
    Other Name: SC Weekly Injection
  • Drug: Victoza®
    Other Name: daily SC injection
  • Experimental: Glymera
    Glymera SC Weekly Injection
    Interventions:
    • Drug: 50 mg Glymera
    • Drug: 70 mg Glymera
    • Drug: 100 mg Glymera
  • Placebo Comparator: Placebo Comparator
    Placebo (0.9% Sodium Chloride) - SC Weekly Injection
    Intervention: Drug: Placebo (0.9% Sodium Chloride)
  • Active Comparator: Active comparator
    Active comparator (Victoza®) daily SC injection
    Intervention: Drug: Victoza®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
593
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01658501
PB1023-PT-CL-0004
Yes
PhaseBio Pharmaceuticals Inc.
PhaseBio Pharmaceuticals Inc.
Not Provided
Not Provided
PhaseBio Pharmaceuticals Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP