Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus (DURATION-NEO-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01652729
First received: July 26, 2012
Last updated: July 22, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Diabetes Type 2
Drug: Exenatide once weekly suspension
Drug: Sitagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo 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 to Week 28 ] [ Designated as safety issue: No ]

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

Enrollment: 366
Study Start Date: February 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide once weekly suspension
Exenatide once weekly suspension 2mg subcutaneous injection
Drug: Exenatide once weekly suspension
Active Comparator: Sitagliptin 100mg
Sitagliptin 100mg oral tablet once daily
Drug: Sitagliptin
Placebo Comparator: Placebo
Placebo oral tablet once daily

  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 of 7.1% to 11.0%, inclusive, at screening
  • Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
  • Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening
  • Body mass index of <45 kg/m2 at screening
  • Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)

Exclusion Criteria:

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min
  • Active cardiovascular disease
  • Presence or history of severe congestive heart failure
  • Central nervous system disease, including epilepsy
  • Liver disease
  • History of severe gastrointestinal diseases
  • Clinically significant malignant disease
  • Repeated severe hypoglycemia within the last 6 months
  • Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
  • Any DPP-4 inhibitor within 3 months prior screening
  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: NCT01652729

  Hide Study Locations
Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35216
Research Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85020
Research Site
Phoenix, Arizona, United States, 85018
United States, California
Research Site
Beverly Hills, California, United States, 90036
Research Site
Buena Park, California, United States, 90620
Research Site
Chino, California, United States, 91710
Research Site
Chula Vista, California, United States, 91910
Research Site
Encinitas, California, United States, 92024
Research Site
Greenbrae, California, United States, 94904
Research Site
Los Angeles, California, United States, 90059
Research Site
Los Angeles, California, United States, 90057
Research Site
North Hollywood, California, United States, 91606
Research Site
Walnut Creek, California, United States, 94598
Research Site
West Hills, California, United States, 91307
United States, Florida
Research Site
Boca Raton, Florida, United States, 33432
Research Site
Hialeah, Florida, United States, 33012
Research Site
Miami, Florida, United States, 33183
Research Site
Miami, Florida, United States, 33143
Research Site
Miami, Florida, United States, 33169
Research Site
Port Orange, Florida, United States, 32127
Research Site
St. Petersburg, Florida, United States, 33709
United States, Illinois
Research Site
Chicago, Illinois, United States, 60607
Research Site
Evanston, Illinois, United States, 60201
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46254
United States, Maryland
Research Site
Oxon Hill, Maryland, United States, 20745
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68130
United States, Nevada
Research Site
Henderson, Nevada, United States, 89052
Research Site
Las Vegas, Nevada, United States, 89101
Research Site
Las Vegas, Nevada, United States, 89123
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Research Site
Buffalo, New York, United States, 14215
Research Site
Hartsdale, New York, United States, 10530
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28204
Research Site
Clayton, North Carolina, United States, 27520
Research Site
Durham, North Carolina, United States, 27710
Research Site
Greensboro, North Carolina, United States, 27410
Research Site
Mooresville, North Carolina, United States, 28117
Research Site
Salisbury, North Carolina, United States, 28144
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45246
Research Site
Franklin, Ohio, United States, 45005
Research Site
Marion, Ohio, United States, 43302
United States, Oklahoma
Research Site
Yukon, Oklahoma, United States, 73099
United States, Oregon
Research Site
Eugene, Oregon, United States, 97404
Research Site
Portland, Oregon, United States, 97210
United States, South Carolina
Research Site
Greer, South Carolina, United States, 29651
Research Site
Simpsonville, South Carolina, United States, 29681
United States, South Dakota
Reseach Site
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37421
United States, Texas
Research Site
Carrolton, Texas, United States, 75007
Research Site
Corpus Christi, Texas, United States, 78404
Research Site
Dallas, Texas, United States, 75390
Research Site
Houston, Texas, United States, 77074
Research Site
Houston, Texas, United States, 77072
Research Site
Katy, Texas, United States, 77450
Research Site
San Antonio, Texas, United States, 78205
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84107
Research Site
Salt Lake City, Utah, United States, 84095
United States, Virginia
Research Site
Burke, Virginia, United States, 22015
United States, Washington
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: NCT01652729     History of Changes
Other Study ID Numbers: BCB120, MB001-004
Study First Received: July 26, 2012
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Diabetes, Type 2, exenatide, Sitagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014