Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea
1 other identifier
interventional
467
16 countries
75
Brief Summary
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Apr 2008
75 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
March 17, 2008
CompletedFirst Posted
Study publicly available on registry
March 21, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
July 4, 2012
CompletedJune 15, 2015
May 1, 2015
1.1 years
March 17, 2008
February 14, 2012
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to Week 26
Change in HbA1c from baseline to Week 26
Baseline, Week 26
Secondary Outcomes (9)
Percentage of Patients Achieving HbA1c <=7.0% at Week 26
Baseline, Week 26
Percentage of Patients Achieving HbA1c <=6.5% at Week 26
Baseline, Week 26
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Baseline, Week 26
Change in Body Weight (BW) From Baseline to Week 26
Baseline, Week 26
Change in Total Cholesterol From Baseline to Week 26
Baseline, Week 26
- +4 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Has type 2 diabetes and at least 18 years of age at screening.
- Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
- Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
- Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).
- Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
- Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
You may not qualify if:
- Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
- Have a history of renal transplantation or are currently receiving renal dialysis.
- Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.
- Have any contraindication for the oral antidiabetic agent which they use.
- Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
- Are known to have active proliferative retinopathy.
- Have been treated with drugs that promote weight loss (e.g., Xenical® \[orlistat\], Meridia® \[sibutramine\], Acomplia® \[rimonabant\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of screening.
- Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
- Insulin
- Thiazolidinediones (e.g., Actos® \[pioglitazone\] or Avandia® \[rosiglitazone\])
- Alpha-glucosidase inhibitors (e.g., Glyset® \[miglitol\] or Precose® \[acarbose\])
- Meglitinides (e.g., Prandin® \[repaglinide\] or Starlix® \[nateglinide\]).
- Byetta® (exenatide BID formulation)
- Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ \[sitagliptin\], Galvus® \[vildagliptin\])
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (75)
Research Site
Escondido, California, United States
Research Site
Jacksonville, Florida, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
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Honolulu, Hawaii, United States
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Idaho Falls, Idaho, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Dayton, Ohio, United States
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Ada, Oklahoma, United States
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San Antonio, Texas, United States
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Spokane, Washington, United States
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Wollongong, New South Wales, Australia
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Herston, Queensland, Australia
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Adelaide, South Australia, Australia
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Keswick, South Australia, Australia
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Box Hill, Victoria, Australia
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Geelong, Victoria, Australia
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Brussels, Belgium
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Edegem, Belgium
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Mělník, Czechia
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Prague, Czechia
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Stodůlky, Czechia
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Aalborg, Denmark
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Arhus C, Denmark
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Herlev, Denmark
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Køge, Denmark
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Angers, France
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Corbeil Essoness, France
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Nancy, France
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Nanterre, France
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Toulouse, France
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Bad Mergentheim, Germany
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Dresden, Germany
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Essen, Germany
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Falkensee, Germany
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Fulda, Germany
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Münster, Germany
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Othmarschen, Germany
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Rothenburg An Der Fulda, Germany
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Speyer, Germany
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Athens, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Eger, Hungary
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Gyula, Hungary
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Pécs, Hungary
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Mexico City, Mexico
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Mérida, Mexico
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Tampico, Mexico
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Tijuana, Mexico
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Amsterdam, Netherlands
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Gouda, Netherlands
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Hoogeveen, Netherlands
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Rotterdam, Netherlands
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Zwijndrecht, Netherlands
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Zwolle, Netherlands
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Caguas, Puerto Rico
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Yabucoa, Puerto Rico
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Moscow, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Alicante, Spain
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Alzira-Valencia, Spain
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Barcelona, Spain
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Bilbao, Spain
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Madrid, Spain
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Málaga, Spain
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Teruel, Spain
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Chiayi City, Taiwan
Research Site
Tainan County, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan
Related Publications (7)
Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012 Apr;35(4):683-9. doi: 10.2337/dc11-1233. Epub 2012 Feb 22.
PMID: 22357185RESULTGuja 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: 32306296DERIVEDDiamant M, Van Gaal L, Guerci B, Stranks S, Han J, Malloy J, Boardman MK, Trautmann ME. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014 Jun;2(6):464-73. doi: 10.1016/S2213-8587(14)70029-4. Epub 2014 Apr 4.
PMID: 24731672DERIVEDGrimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
PMID: 23748506DERIVEDMeloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48.
PMID: 23522121DERIVEDFineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
PMID: 22236356DERIVEDDiamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0.
PMID: 20609969DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Chief Medical Officer, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
March 17, 2008
First Posted
March 21, 2008
Study Start
April 1, 2008
Primary Completion
May 1, 2009
Study Completion
November 1, 2009
Last Updated
June 15, 2015
Results First Posted
July 4, 2012
Record last verified: 2015-05