Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
DURATION-NEO-1
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
2 other identifiers
interventional
377
1 country
58
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Jan 2013
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
September 16, 2015
CompletedJuly 3, 2018
May 1, 2018
1.6 years
July 26, 2012
August 4, 2015
June 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
The primary objective of this study was 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.
Baseline to Week 28
Secondary Outcomes (4)
Percentage of Subjects Achieving HbA1c <7% at Week 28
Baseline to Week 28
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Baseline to Week 28
Change in Body Weight (kg) From Baseline to Week 28
Baseline to Week 28
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16
Baseline to Week 16
Study Arms (2)
Exenatide once weekly suspension
EXPERIMENTALExenatide suspension 2 mg weekly subcutaneous injection
Exenatide twice daily (BID)
ACTIVE COMPARATORExenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
Interventions
Exenatide suspension 2 mg weekly subcutaneous injection
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (58)
Research Site
Muscle Shoals, Alabama, 35662, United States
Research Site
Mesa, Arizona, 85206, United States
Research Site
Phoenix, Arizona, 85020, United States
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Little Rock, Arkansas, 72205, United States
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Escondido, California, 92026, United States
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Garden Grove, California, 92844, United States
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Lomita, California, 90717, United States
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Los Angeles, California, 90015, United States
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Santa Ana, California, 92705, United States
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Spring Valley, California, 91978, United States
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Walnut Creek, California, 94598, United States
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Denver, Colorado, 80220, United States
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Coral Gables, Florida, 33134, United States
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DeLand, Florida, 32720, United States
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Kissimmee, Florida, 34741, United States
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Miami, Florida, 33156, United States
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Orlando, Florida, 32806, United States
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Oviedo, Florida, 32765, United States
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Palm Harbor, Florida, 34684, United States
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Ponte Vedra, Florida, 32081, United States
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Chicago, Illinois, 60607, United States
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Chicago, Illinois, 60616, United States
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Lexington, Kentucky, 40503, United States
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Paducah, Kentucky, 42003, United States
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Lake Charles, Louisiana, 70601, United States
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Columbia, Maryland, 21045, United States
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Elkridge, Maryland, 21075, United States
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Hyattsville, Maryland, 20782, United States
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New Bedford, Massachusetts, 02740, United States
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Detroit, Michigan, 48202, United States
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Troy, Michigan, 48098, United States
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Edina, Minnesota, 55435, United States
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Port Gibson, Mississippi, 39150, United States
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St Louis, Missouri, 63128, United States
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Butte, Montana, 59701, United States
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Henderson, Nevada, 89052, United States
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Endwell, New York, 13760, United States
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New Windsor, New York, 12553, United States
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Greensboro, North Carolina, 27408, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45227, United States
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Columbus, Ohio, 43213, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73112, United States
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Portland, Oregon, 97239, United States
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Harleysville, Pennsylvania, 19438, United States
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Charleston, South Carolina, 29407, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Dallas, Texas, 75230, United States
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Houston, Texas, 77062, United States
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San Antonio, Texas, 78205, United States
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Murray, Utah, 84123, United States
Research Site
Salt Lake City, Utah, 84107, United States
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Manassas, Virginia, 20110, United States
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Norfolk, Virginia, 23502, United States
Research Site
Richmond, Virginia, 23294, United States
Research Site
Olympia, Washington, 98502, United States
Research Site
Spokane, Washington, 99202, United States
Related Publications (2)
Wysham CH, Rosenstock J, Vetter ML, Wang H, Hardy E, Iqbal N. Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e000773. doi: 10.1136/bmjdrc-2019-000773.
PMID: 33037036DERIVEDWysham CH, Rosenstock J, Vetter ML, Dong F, Ohman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):165-172. doi: 10.1111/dom.13056. Epub 2017 Aug 22.
PMID: 28685973DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- ClinicalTrialTransparency@astrazeneca.com
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Vice President Medical Research & Development, M.D.
Amylin Pharmaceuticals, LLC.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2012
First Posted
July 30, 2012
Study Start
January 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
July 3, 2018
Results First Posted
September 16, 2015
Record last verified: 2018-05