Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes (DURATION-NEO-1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01652716
First received: July 26, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Exenatide once weekly suspension
Drug: Exenatide twice daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving HbA1c <7% at Week 28 [ Time Frame: Baseline (Day 1) and Week 28 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose concentrations from baseline to Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]
  • Change in body weight (kg) from baseline to Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]
  • Change in 2-hour postprandial glucose concentrations from baseline to Week 16 [ Time Frame: Baseline (Day 1) to Week 16 ] [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated hemoglobin) from baseline to Week 52 [ Time Frame: Baseline (Day 1) to Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1c <= 6.5% at Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
Drug: Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
Active Comparator: Exenatide twice daily (BID)
Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
Drug: Exenatide twice daily
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Other Name: Byetta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c 7.1 to 11%, inclusive, at screening
  • Fasting plasma glucose <280 mg/dL (15.5 mmol/L)
  • Body mass index (BMI) <=45 kg/m2, inclusive, at screening
  • Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion Criteria:

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • Active cardiovascular disease
  • Presence of congestive heart failure
  • Liver disease
  • History of severe gastrointestinal diseases
  • Repeated severe hypoglycemia within the last 6 months
  • Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
  • Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
  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: NCT01652716

  Hide Study Locations
Locations
United States, Alabama
Research Site
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Research Site
Mesa, Arizona, United States, 85206
Research Site
Phoenix, Arizona, United States, 85020
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72205
United States, California
Research Site
Escondido, California, United States, 92026
Research Site
Garden Grove, California, United States, 92844
Research Site
Lomita, California, United States, 90717
Research Site
Los Angeles, California, United States, 90015
Research Site
Santa Ana, California, United States, 92705
Research Site
Spring Valley, California, United States, 91978
Research Site
Walnut Creek, California, United States, 94598
United States, Colorado
Research Site
Denver, Colorado, United States, 80220
United States, Florida
Research Site
Coral Gables, Florida, United States, 33134
Research Site
Deland, Florida, United States, 32720
Research Site
Kissimmee, Florida, United States, 34741
Research Site
Miami, Florida, United States, 33156
Research Site
Orlando, Florida, United States, 32806
Research Site
Oviedo, Florida, United States, 32765
Research Site
Palm Harbor, Florida, United States, 34684
Research Site
Ponte Vedra, Florida, United States, 32081
United States, Illinois
Research Site
Chicago, Illinois, United States, 60607
Research Site
Chicago, Illinois, United States, 60616
United States, Kentucky
Research Site
Lexington, Kentucky, United States, 40503
Research Site
Paducah, Kentucky, United States, 42003
United States, Louisiana
Research Site
Lake Charles, Louisiana, United States, 70601
United States, Maryland
Research Site
Columbia, Maryland, United States, 21045
Research Site
Elkridge, Maryland, United States, 21075
Research Site
Hyattsville, Maryland, United States, 20782
United States, Massachusetts
Research Site
New Bedford, Massachusetts, United States, 02740
United States, Michigan
Research Site
Detroit, Michigan, United States, 48202
Research Site
Troy, Michigan, United States, 48098
United States, Minnesota
Research Site
Edina, Minnesota, United States, 55435
United States, Mississippi
Research Site
Port Gibson, Mississippi, United States, 39150
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63128
United States, Montana
Research Site
Butte, Montana, United States, 59701
United States, Nevada
Research Site
Henderson, Nevada, United States, 89052
United States, New York
Research Site
Endwell, New York, United States, 13760
Research Site
New Windsor, New York, United States, 12553
United States, North Carolina
Research Site
Greensboro, North Carolina, United States, 27408
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45219
Research Site
Cincinnati, Ohio, United States, 45227
Research Site
Columbus, Ohio, United States, 43213
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73103
Research Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Research Site
Harleysville, Pennsylvania, United States, 19438
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29407
Research Site
Mount Pleasant, South Carolina, United States, 29464
Research Site
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Research Site
Dallas, Texas, United States, 75230
Research Site
Houston, Texas, United States, 77062
Research Site
San Antonio, Texas, United States, 78205
United States, Utah
Research Site
Murray, Utah, United States, 84123
Research Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Research Site
Manassas, Virginia, United States, 20110
Research Site
Norfolk, Virginia, United States, 23502
Research Site
Richmond, Virginia, United States, 23294
United States, Washington
Research Site
Olympia, Washington, United States, 98502
Research Site
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Vice President Medical Research & Development, M.D. Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01652716     History of Changes
Other Study ID Numbers: BCB118, MB001-003
Study First Received: July 26, 2012
Last Updated: November 4, 2013
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
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014