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

P

PhaseBio Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Metformin
Drug: Placebo (0.9% Sodium Chloride)
Drug: Sulfonylurea
Drug: 50 mg PB1023
Drug: Victoza®
Drug: 70 mg PB1023
Other: Diet and Exercise
Drug: 100 mg PB1023
Drug: Metformin and Sulfonylurea

Study type

Interventional

Funder types

Industry

Identifiers

NCT01658501
PB1023-PT-CL-0004

Details and patient eligibility

About

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.

Enrollment

593 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

593 participants in 7 patient groups, including a placebo group

Diet and Exercise
Experimental group
Description:
Diet and exercise only.
Treatment:
Drug: 100 mg PB1023
Drug: 70 mg PB1023
Drug: Victoza®
Drug: 50 mg PB1023
Drug: Placebo (0.9% Sodium Chloride)
Metformin
Experimental group
Description:
Metformin only
Treatment:
Drug: 100 mg PB1023
Drug: 70 mg PB1023
Drug: Victoza®
Drug: 50 mg PB1023
Drug: Placebo (0.9% Sodium Chloride)
Sulfonylurea
Experimental group
Description:
Sulfonylurea only
Treatment:
Drug: 100 mg PB1023
Drug: 70 mg PB1023
Drug: Victoza®
Drug: 50 mg PB1023
Drug: Placebo (0.9% Sodium Chloride)
Metformin and Sulfonylurea
Experimental group
Description:
Metformin and Sulfonylurea combination therapy
Treatment:
Drug: 100 mg PB1023
Drug: 70 mg PB1023
Drug: Victoza®
Drug: 50 mg PB1023
Drug: Placebo (0.9% Sodium Chloride)
PB1023
Experimental group
Description:
PB1023 weekly SC injection
Treatment:
Drug: Metformin and Sulfonylurea
Drug: 100 mg PB1023
Other: Diet and Exercise
Drug: 70 mg PB1023
Drug: Sulfonylurea
Drug: 50 mg PB1023
Drug: Metformin
Placebo Comparator
Placebo Comparator group
Description:
Placebo (0.9% Sodium Chloride) weekly SC injection
Treatment:
Drug: Metformin and Sulfonylurea
Other: Diet and Exercise
Drug: Sulfonylurea
Drug: Metformin
Drug: Placebo (0.9% Sodium Chloride)
Active Comparator
Active Comparator group
Description:
Active Comparator (Victoza) daily SC injection
Treatment:
Drug: Metformin and Sulfonylurea
Other: Diet and Exercise
Drug: Victoza®
Drug: Sulfonylurea
Drug: Metformin

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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