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
A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin
2 other identifiers
interventional
695
6 countries
133
Brief Summary
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus
Started Sep 2014
Typical duration for phase_3 diabetes-mellitus
133 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
August 28, 2014
CompletedFirst Posted
Study publicly available on registry
September 1, 2014
CompletedStudy Start
First participant enrolled
September 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2016
CompletedResults Posted
Study results publicly available
September 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2017
CompletedDecember 31, 2018
December 1, 2018
1.6 years
August 28, 2014
August 9, 2017
December 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to Week 28
To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Baseline to Week 28
Secondary Outcomes (7)
Change in Body Weight From Baseline to Week 28
Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 28
Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
Baseline to Week 28
Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28
Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 2
Baseline to Week 2
- +2 more secondary outcomes
Study Arms (3)
Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
EXPERIMENTALExenatide Once Weekly 2 mg Alone
EXPERIMENTALDapagliflozin Once Daily 10 mg Alone
ACTIVE COMPARATORInterventions
2 mg weekly suspension injection and 10 mg Dapagliflozin
Eligibility Criteria
You may qualify if:
- Has a diagnosis of T2DM.
- 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.
You may not qualify if:
- FPG ≥280 mg/dL (15.6 mmol/L).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (133)
Research Site
Birmingham, Alabama, 35235, United States
Research Site
Huntsville, Alabama, 35801, United States
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Tuscumbia, Alabama, 35674, United States
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Glendale, Arizona, 85306, United States
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Tempe, Arizona, 85283, United States
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Anaheim, California, 92801, United States
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Chula Vista, California, 91911, United States
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El Cajon, California, 92020, United States
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Fresno, California, 93720, United States
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La Mesa, California, 91942, United States
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Long Beach, California, 90807, United States
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Los Angeles, California, 90057, United States
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Mission Hills, California, 91345, United States
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Montclair, California, 91763, United States
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Oceanside, California, 92056, United States
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San Diego, California, 92103, United States
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San Diego, California, 92114, United States
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Tustin, California, 92780, United States
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Van Nuys, California, 91405, United States
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Boynton Beach, Florida, 33437, United States
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Clearwater, Florida, 33765, United States
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Coral Gables, Florida, 33134, United States
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Fort Lauderdale, Florida, 33316, United States
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Hialeah, Florida, 33012, United States
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Jacksonville, Florida, 32256, United States
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Jacksonville, Florida, 32277, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33133, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33142, United States
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Miami, Florida, 33165, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33186, United States
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North Miami Beach, Florida, 33162, United States
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Orlando, Florida, 32801, United States
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Orlando, Florida, 32806, United States
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Tampa, Florida, 33603, United States
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Williston, Florida, 32696, United States
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Chicago, Illinois, 60607, United States
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Avon, Indiana, 46123, United States
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Evansville, Indiana, 47714, United States
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Franklin, Indiana, 46131, United States
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Muncie, Indiana, 47304, United States
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Newton, Kansas, 67114, United States
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Monroe, Louisiana, 71201, United States
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Hazelwood, Missouri, 63042, United States
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Bellevue, Nebraska, 68005, United States
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Las Vegas, Nevada, 89109, United States
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Haddon Heights, New Jersey, 08035, United States
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Burlington, North Carolina, 27215, United States
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Greensboro, North Carolina, 27408, United States
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Mooresville, North Carolina, 28117, United States
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Morehead City, North Carolina, 28557, United States
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Cincinnati, Ohio, 45242, United States
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Vandalia, Ohio, 45377, United States
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Medford, Oregon, 97504, United States
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Philadelphia, Pennsylvania, 91307, United States
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Charleston, South Carolina, 29407, United States
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Greer, South Carolina, 29651, United States
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Spartanburg, South Carolina, 29303, United States
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Summerville, South Carolina, 29485, United States
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Dakota Dunes, South Dakota, 57049, United States
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Memphis, Tennessee, 38119, United States
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Dallas, Texas, 75218, United States
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Dallas, Texas, 75230, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77079, United States
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Houston, Texas, 77090, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78229, United States
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Tomball, Texas, 77375, United States
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Clinton, Utah, 84015, United States
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Salt Lake City, Utah, 84102, United States
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Burke, Virginia, 22015, United States
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Manassas, Virginia, 20110, United States
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Richmond, Virginia, 23294, United States
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Baja, 6500, Hungary
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Balatonfüred, 8230, Hungary
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Budaörs, 2040, Hungary
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Budapest, 1033, Hungary
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Budapest, 1083, Hungary
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Budapest, 1088, Hungary
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Debrecen, 4025, Hungary
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Eger, 3300, Hungary
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Gödöllő, 2100, Hungary
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Gyula, 5700, Hungary
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Kecskemét, 6000, Hungary
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Komárom, 2921, Hungary
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Létavértes, 4281, Hungary
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Nyíregyháza, 4405, Hungary
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Pécs, 7623, Hungary
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Szeged, 6722, Hungary
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Szekszárd, 7100, Hungary
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Lodz, 94-048, Poland
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Lodz, 94-255, Poland
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Lublin, 20-538, Poland
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Oświęcim, 32-600, Poland
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Parczew, 21-200, Poland
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Poznan, 61-655, Poland
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Torun, 87-100, Poland
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Zgierz, 95-100, Poland
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Baia Mare, 430222, Romania
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Bucharest, 010192, Romania
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Bucharest, 010825, Romania
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Bucharest, 020475, Romania
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Galati, 800578, Romania
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Oradea, 410032, Romania
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Oradea, 410169, Romania
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Oradea, 410469, Romania
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Ploieşti, 100342, Romania
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Timișoara, 300456, Romania
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Banská Bystrica, 97517, Slovakia
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Bardejov, 085 01, Slovakia
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Bratislava, 81108, Slovakia
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Bratislava, 82106, Slovakia
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Bratislava, 85101, Slovakia
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Dolný Kubín, 026 01, Slovakia
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Košice, 04001, Slovakia
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Levice, 934 01, Slovakia
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Levice, 93401, Slovakia
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Lučenec, 984 01, Slovakia
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Nitra, 94911, Slovakia
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Pezinok, 90201, Slovakia
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Štúrovo, 943 01, Slovakia
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Trebišov, 07501, Slovakia
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Bloemfontein, 9301, South Africa
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Cape Town, 7925, South Africa
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Johannesburg, 1818, South Africa
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Kempton Park, 1619, South Africa
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Middelburg, 1055, South Africa
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Parow, 7505, South Africa
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Port Elizabeth, 6014, South Africa
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Pretoria, 0001, South Africa
Related Publications (4)
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.
PMID: 32816874DERIVEDGuja 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: 32306296DERIVEDJabbour 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.
PMID: 30082326DERIVEDFrias 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.
PMID: 27651331DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Leader
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2014
First Posted
September 1, 2014
Study Start
September 4, 2014
Primary Completion
April 26, 2016
Study Completion
December 28, 2017
Last Updated
December 31, 2018
Results First Posted
September 8, 2017
Record last verified: 2018-12