Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin
2 other identifiers
interventional
464
6 countries
123
Brief Summary
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus
Started Sep 2014
123 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 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2016
CompletedResults Posted
Study results publicly available
September 18, 2017
CompletedJanuary 8, 2019
December 1, 2018
2 years
August 28, 2014
August 18, 2017
December 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to Week 28
To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.
Baseline to Week 28
Secondary Outcomes (6)
Change in Body Weight 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 (MTT)
Baseline to Week 28
Percentage of Participants Achieving HbA1c <7.0% at Week 28
Baseline to Week 28
Change From Baseline to Week 28 in Daily Insulin Dose
Baseline to Week 28
Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks
Baseline to Week 28
- +1 more secondary outcomes
Study Arms (2)
Exenatide
EXPERIMENTALExenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Placebo
PLACEBO COMPARATORPlacebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Interventions
Eligibility Criteria
You may qualify if:
- Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).
- Has fasting plasma glucose (FPG) concentration \<280 mg/dL (15.6 mmol/L) at Visit 1 (Screening)
- Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with:
- a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
- a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit
You may not qualify if:
- Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
- History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
- Positive serological test for hepatitis B or hepatitis C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (123)
Research Site
Birmingham, Alabama, 35235, United States
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Huntsville, Alabama, 35801, United States
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Muscle Shoals, Alabama, 35662, United States
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Tempe, Arizona, 85283, United States
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Chino, California, 91710, United States
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Chula Vista, California, 91910, 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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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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Tustin, California, 92780, United States
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West Hills, California, 91307, United States
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Boynton Beach, Florida, 33437, United States
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Brooksville, Florida, 34601, United States
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Chiefland, Florida, 32626, 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, 33125, 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, 33142, United States
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Miami, Florida, 33175, United States
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North Miami Beach, Florida, 33162, United States
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Orlando, Florida, 32806, United States
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Tampa, Florida, 33603, United States
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Columbus, Georgia, 31406, 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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Newton, Kansas, 67114, United States
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Monroe, Louisiana, 71203, United States
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New Orleans, Louisiana, 70112, United States
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Hazelwood, Missouri, 63042, United States
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Bellevue, Nebraska, 68005, United States
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Omaha, Nebraska, 68114, United States
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Haddon Heights, New Jersey, 08035, 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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Morganton, North Carolina, 28655, United States
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Cincinnati, Ohio, 45242, United States
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Cleveland, Ohio, 44122, United States
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Dayton, Ohio, 45417, United States
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Medford, Oregon, 97504, United States
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Philadelphia, Pennsylvania, 91307, 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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Dakota Dunes, South Dakota, 57049, United States
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Johnson City, Tennessee, 37604, United States
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Kingsport, Tennessee, 37660, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75208, United States
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Dallas, Texas, 75230, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77070, United States
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Houston, Texas, 77079, United States
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Houston, Texas, 77090, United States
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Clinton, Utah, 84015, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84102, United States
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Manassas, Virginia, 20110, United States
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Richmond, Virginia, 23294, United States
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Port Orchard, Washington, 98366, United States
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Baja, 6500, Hungary
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Balatonfüred, 8230, Hungary
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Budapest, 1033, Hungary
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Budapest, 1036, Hungary
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Budapest, 1083, Hungary
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Budapest, 1088, Hungary
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Budapest, 1134, Hungary
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Debrecen, 4032, 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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Komárom, 2921, Hungary
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Létavértes, 4281, Hungary
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Pécs, 7623, Hungary
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Sátoraljaújhely, 3980, 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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Lublin, 20-363, Poland
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Lublin, 20-538, Poland
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Oświęcim, 32-600, Poland
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Poznan, 61-655, Poland
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Torun, 87-100, Poland
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Zamość, 22-400, 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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Ploieşti, 100342, Romania
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Tg Mures, 540142, Romania
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Timișoara, 300456, Romania
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Bardejov, 08501, Slovakia
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Bratislava, 81108, Slovakia
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Bratislava, 82106, 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, 94901, Slovakia
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Nitra, 94911, Slovakia
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Prešov, 080 01, Slovakia
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Štúrovo, 94301, Slovakia
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Bloemfontein, 9301, South Africa
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Kempton Park, 1619, South Africa
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Krugersdorp, 1739, South Africa
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Paarl, 7646, South Africa
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Pretoria, 0087, South Africa
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Pretoria, 184, South Africa
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Somerset West, 7130, South Africa
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Worcester, 6850, South Africa
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: 32306296DERIVEDGuja C, Frias JP, Somogyi A, Jabbour S, Wang H, Hardy E, Rosenstock J. Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study. Diabetes Obes Metab. 2018 Jul;20(7):1602-1614. doi: 10.1111/dom.13266. Epub 2018 Mar 25.
PMID: 29473704DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Please note that the data from 4 subjects enrolled at one site were omitted due to potential scientific misconduct at that site. Study conclusions remain unchanged.
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 6, 2014
Primary Completion
August 29, 2016
Study Completion
August 29, 2016
Last Updated
January 8, 2019
Results First Posted
September 18, 2017
Record last verified: 2018-12