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
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
2 other identifiers
interventional
365
1 country
60
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2013
Shorter than P25 for phase_3
60 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
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
April 23, 2015
CompletedAugust 20, 2015
July 1, 2015
1.2 years
July 26, 2012
April 3, 2015
July 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
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 (Visit 8)
Baseline to Week 16
Study Arms (3)
Exenatide once weekly suspension
EXPERIMENTALExenatide once weekly suspension 2mg subcutaneous injection
Sitagliptin 100mg
ACTIVE COMPARATOROverencapsulated Sitagliptin 100mg oral tablet once daily
Placebo
PLACEBO COMPARATORPlacebo oral capsule once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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)
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (60)
Research Site
Birmingham, Alabama, 35216, United States
Research Site
Huntsville, Alabama, 35801, United States
Research Site
Phoenix, Arizona, 85018, United States
Research Site
Phoenix, Arizona, 85020, United States
Research Site
Beverly Hills, California, 90036, United States
Research Site
Buena Park, California, 90620, United States
Research Site
Chino, California, 91710, United States
Research Site
Chula Vista, California, 91910, United States
Research Site
Encinitas, California, 92024, United States
Research Site
Greenbrae, California, 94904, United States
Research Site
Los Angeles, California, 90057, United States
Research Site
Los Angeles, California, 90059, United States
Research Site
North Hollywood, California, 91606, United States
Research Site
Walnut Creek, California, 94598, United States
Research Site
West Hills, California, 91307, United States
Research Site
Boca Raton, Florida, 33432, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Miami, Florida, 33143, United States
Research Site
Miami, Florida, 33169, United States
Research Site
Miami, Florida, 33183, United States
Research Site
Port Orange, Florida, 32127, United States
Research Site
St. Petersburg, Florida, 33709, United States
Research Site
Chicago, Illinois, 60607, United States
Research Site
Evanston, Illinois, 60201, United States
Research Site
Indianapolis, Indiana, 46254, United States
Research Site
Oxon Hill, Maryland, 20745, United States
Research Site
Omaha, Nebraska, 68130, United States
Research Site
Henderson, Nevada, 89052, United States
Research Site
Las Vegas, Nevada, 89101, United States
Research Site
Las Vegas, Nevada, 89123, United States
Research Site
Albuquerque, New Mexico, 87102, United States
Research Site
Buffalo, New York, 14215, United States
Research Site
Hartsdale, New York, 10530, United States
Research Site
Charlotte, North Carolina, 28204, United States
Research Site
Clayton, North Carolina, 27520, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Greensboro, North Carolina, 27410, United States
Research Site
Mooresville, North Carolina, 28117, United States
Research Site
Salisbury, North Carolina, 28144, United States
Research Site
Cincinnati, Ohio, 45246, United States
Research Site
Franklin, Ohio, 45005, United States
Research Site
Marion, Ohio, 43302, United States
Research Site
Yukon, Oklahoma, 73099, United States
Research Site
Eugene, Oregon, 97404, United States
Research Site
Portland, Oregon, 97210, United States
Research Site
Greer, South Carolina, 29651, United States
Research Site
Simpsonville, South Carolina, 29681, United States
Reseach Site
Rapid City, South Dakota, 57702, United States
Research Site
Chattanooga, Tennessee, 37421, United States
Research Site
Carrolton, Texas, 75007, United States
Research Site
Corpus Christi, Texas, 78404, United States
Research Site
Dallas, Texas, 75390, United States
Research Site
Houston, Texas, 77072, United States
Research Site
Houston, Texas, 77074, United States
Research Site
Katy, Texas, 77450, United States
Research Site
San Antonio, Texas, 78205, United States
Research Site
Salt Lake City, Utah, 84095, United States
Research Site
Salt Lake City, Utah, 84107, United States
Research Site
Burke, Virginia, 22015, United States
Research Site
Spokane, Washington, 99202, United States
Related Publications (2)
Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
PMID: 32306296DERIVEDGadde KM, Vetter ML, Iqbal N, Hardy E, Ohman P; DURATION-NEO-2 study investigators. Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study. Diabetes Obes Metab. 2017 Jul;19(7):979-988. doi: 10.1111/dom.12908. Epub 2017 Mar 17.
PMID: 28205322DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- ClinicalTrialTransparency@astrazeneca.com
- Organization
- AstraZeneca
Study Officials
- STUDY CHAIR
Peter Ohman
AstraZeneca
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
February 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 20, 2015
Results First Posted
April 23, 2015
Record last verified: 2015-07