Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
NCT ID: NCT02229396
Last Updated: 2018-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
695 participants
INTERVENTIONAL
2014-09-04
2017-12-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
Exantide with Dapagliflozin
2 mg weekly suspension injection and 10 mg Dapagliflozin
Exenatide Once Weekly 2 mg Alone
Exentide
2 mg
Dapagliflozin Once Daily 10 mg Alone
Dapagliflozin
10 mg once daily Dapagliflozin
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exantide with Dapagliflozin
2 mg weekly suspension injection and 10 mg Dapagliflozin
Exentide
2 mg
Dapagliflozin
10 mg once daily Dapagliflozin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.
* Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.
Exclusion Criteria
* Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
* Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator.
* Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded.
* Known active proliferative retinopathy.
* History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
* History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
* History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
Research Site
Tuscumbia, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Tempe, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
Research Site
El Cajon, California, United States
Research Site
Fresno, California, United States
Research Site
La Mesa, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Mission Hills, California, United States
Research Site
Montclair, California, United States
Research Site
Oceanside, California, United States
Research Site
San Diego, California, United States
Research Site
San Diego, California, United States
Research Site
Tustin, California, United States
Research Site
Van Nuys, California, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Coral Gables, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
North Miami Beach, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Williston, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Avon, Indiana, United States
Research Site
Evansville, Indiana, United States
Research Site
Franklin, Indiana, United States
Research Site
Muncie, Indiana, United States
Research Site
Newton, Kansas, United States
Research Site
Monroe, Louisiana, United States
Research Site
Hazelwood, Missouri, United States
Research Site
Bellevue, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Haddon Heights, New Jersey, United States
Research Site
Burlington, North Carolina, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Mooresville, North Carolina, United States
Research Site
Morehead City, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Vandalia, Ohio, United States
Research Site
Medford, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Greer, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Summerville, South Carolina, United States
Research Site
Dakota Dunes, South Dakota, United States
Research Site
Memphis, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Pearland, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Tomball, Texas, United States
Research Site
Clinton, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Burke, Virginia, United States
Research Site
Manassas, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Baja, , Hungary
Research Site
Balatonfüred, , Hungary
Research Site
Budaörs, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Eger, , Hungary
Research Site
Gödöllő, , Hungary
Research Site
Gyula, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Komárom, , Hungary
Research Site
Létavértes, , Hungary
Research Site
Nyíregyháza, , Hungary
Research Site
Pécs, , Hungary
Research Site
Szeged, , Hungary
Research Site
Szekszárd, , Hungary
Research Site
Lodz, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Oświęcim, , Poland
Research Site
Parczew, , Poland
Research Site
Poznan, , Poland
Research Site
Torun, , Poland
Research Site
Zgierz, , Poland
Research Site
Baia Mare, , Romania
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Bucharest, , Romania
Research Site
Galati, , Romania
Research Site
Oradea, , Romania
Research Site
Oradea, , Romania
Research Site
Oradea, , Romania
Research Site
Ploieşti, , Romania
Research Site
Timișoara, , Romania
Research Site
Banská Bystrica, , Slovakia
Research Site
Bardejov, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Dolný Kubín, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Levice, , Slovakia
Research Site
Levice, , Slovakia
Research Site
Lučenec, , Slovakia
Research Site
Nitra, , Slovakia
Research Site
Pezinok, , Slovakia
Research Site
Štúrovo, , Slovakia
Research Site
Trebišov, , Slovakia
Research Site
Bloemfontein, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Kempton Park, , South Africa
Research Site
Middelburg, , South Africa
Research Site
Parow, , South Africa
Research Site
Port Elizabeth, , South Africa
Research Site
Pretoria, , South Africa
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jabbour SA, Frias JP, Ahmed A, Hardy E, Choi J, Sjostrom CD, Guja C. Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial. Diabetes Care. 2020 Oct;43(10):2528-2536. doi: 10.2337/dc19-1350. Epub 2020 Aug 18.
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.
Jabbour SA, Frias JP, Hardy E, Ahmed A, Wang H, Ohman P, Guja C. Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the DURATION-8 Randomized Controlled Trial. Diabetes Care. 2018 Oct;41(10):2136-2146. doi: 10.2337/dc18-0680. Epub 2018 Aug 6.
Frias JP, Guja C, Hardy E, Ahmed A, Dong F, Ohman P, Jabbour SA. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Dec;4(12):1004-1016. doi: 10.1016/S2213-8587(16)30267-4. Epub 2016 Sep 16.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-003503-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5553C00003
Identifier Type: -
Identifier Source: org_study_id