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

NCT01658501 | Completed Phase 2 DMC

• 1 other identifier: PB1023-PT-CL-0004
• Study Type: interventional
• Target: 593
• Locations: 1 country
• Sites: 93

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

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

  Up to 23 weeks

• 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

• Describe the frequencies of adverse events in the treatment groups

  Up to 23 weeks

• Proportion of subjects reaching HbA1c targets (<7.0%) after 20 weeks of dosing

  Baseline and 20 weeks

Study Arms (7)

Diet and Exercise

EXPERIMENTAL

Diet and exercise only.

Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza®

Metformin

EXPERIMENTAL

Metformin only

Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza®

Sulfonylurea

EXPERIMENTAL

Sulfonylurea only

Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza®

Metformin and Sulfonylurea

EXPERIMENTAL

Metformin and Sulfonylurea combination therapy

Drug: 50 mg PB1023; Drug: 70 mg PB1023; Drug: 100 mg PB1023; Drug: Placebo (0.9% Sodium Chloride); Drug: Victoza®

PB1023

EXPERIMENTAL

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: Diet and Exercise; Drug: Metformin; Drug: Sulfonylurea; Drug: Metformin and Sulfonylurea

Active Comparator

ACTIVE COMPARATOR

Active Comparator (Victoza) daily SC injection

Drug: Victoza®; Other: Diet and Exercise; Drug: Metformin; Drug: Sulfonylurea; Drug: Metformin and Sulfonylurea

Interventions

50 mg PB1023 DRUG

Diet and Exercise; Metformin; Metformin and Sulfonylurea; PB1023; Sulfonylurea

70 mg PB1023 DRUG

Diet and Exercise; Metformin; Metformin and Sulfonylurea; PB1023; Sulfonylurea

100 mg PB1023 DRUG

Diet and Exercise; Metformin; Metformin and Sulfonylurea; PB1023; Sulfonylurea

Placebo (0.9% Sodium Chloride) DRUG

Also known as: SC Weekly Injection

Diet and Exercise; Metformin; Metformin and Sulfonylurea; Placebo Comparator; Sulfonylurea

Victoza® DRUG

Also known as: daily SC injection

Active Comparator; Diet and Exercise; Metformin; Metformin and Sulfonylurea; Sulfonylurea

Diet and Exercise OTHER

Active Comparator; PB1023; Placebo Comparator

Metformin DRUG

Active Comparator; PB1023; Placebo Comparator

Sulfonylurea DRUG

Active Comparator; PB1023; Placebo Comparator

Metformin and Sulfonylurea DRUG

Active Comparator; PB1023; Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PhaseBio Pharmaceuticals Inc.: lead

Study Sites (93)

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Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Gulf Shores, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Muscle Shoals, Alabama, United States

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Chandler, Arizona, United States

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Glendale, Arizona, United States

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Goodyear, Arizona, United States

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Tucson, Arizona, United States

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Harrisburg, Arkansas, United States

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Little Rock, Arkansas, United States

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Searcy, Arkansas, United States

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Chula Vista, California, United States

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Concord, California, United States

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Escondido, California, United States

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Hawaiian Gardens, California, United States

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La Mesa, California, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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San Jose, California, United States

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Santa Rosa, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Stamford, Connecticut, United States

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Brandenton, Florida, United States

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Brooksville, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Oviedo, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Roswell, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Council Bluffs, Iowa, United States

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Augusta, Kansas, United States

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Newton, Kansas, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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Oxon Hill, Maryland, United States

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Ypsilanti, Michigan, United States

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Saint Paul, Minnesota, United States

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St Louis, Missouri, United States

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Fremont, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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New Windsor, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Hickory, North Carolina, United States

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Morehead City, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Delaware, Ohio, United States

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Kettering, Ohio, United States

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Lyndhurst, Ohio, United States

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Wadsworth, Ohio, United States

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Willoughby Hills, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Greer, South Carolina, United States

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Spartanburg, South Carolina, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Hurst, Texas, United States

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Katy, Texas, United States

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Magna, Utah, United States

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West Jordan, Utah, United States

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Burke, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Renton, Washington, United States

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Kenosha, Wisconsin, United States

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium Chloride; Liraglutide; Diet; Exercise; Metformin; Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: August 7, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 7, 2015

Record last verified: 2015-11

Locations

US (93)