A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

NCT00877890 | Completed Phase 3 Results

• 1 other identifier: BCB108 (DURATION-5)
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 41

Brief Summary

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; exenatide once weekly; Byetta; Amylin; Lilly; Bydureon

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 24

  Change in HbA1c from baseline (Day 1) to Week 24 \[Week 24 - Baseline\].

  Day 1, Week 24

Secondary Outcomes (12)

• Percentage of Subjects Achieving HbA1c Target of <7%

  Week 24

• Percentage of Subjects Achieving HbA1c Target of <=6.5%

  Week 24

• Change in Fasting Plasma Glucose From Baseline to Week 24

  Day 1, Week 24

• Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL

  Week 24

• Change in Body Weight From Baseline to Week 24

  Day 1, Week 24

Study Arms (2)

1

EXPERIMENTAL

Drug: exenatide once weekly

2

ACTIVE COMPARATOR

Drug: exenatide twice daily

Interventions

exenatide once weekly DRUG

subcutaneous injection, 2.0mg, once a week

Also known as: BYDUREON

1

exenatide twice daily DRUG

subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day

Also known as: BYETTA

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has been diagnosed with type 2 diabetes mellitus
• Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
• Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
• Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening
• Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:
• Hormone replacement therapy (female subjects)
• Oral contraceptives (female subjects)
• Antihypertensive agents
• Lipid-lowering agents
• Thyroid replacement therapy
• Antidepressant agents
• Drugs known to affect body weight, including prescription medications (e.g. orlistat \[XENICAL®\], sibutramine \[MERIDIA®\], topiramate \[TOPAMAX®\]) and over the counter antiobesity agents

You may not qualify if:

• Has ever been exposed to exenatide (exenatide once weekly \[exenatide LAR\], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
• Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
• Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
• Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
• Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
• Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
• Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (41)

Research Site

Birmingham, Alabama, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Artesia, California, United States

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Concord, California, United States

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Encino, California, United States

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Greenbrae, California, United States

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La Mesa, California, United States

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Walnut Creek, California, United States

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DeLand, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Palm Harbor, Florida, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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Evansville, Indiana, United States

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Lexington, Kentucky, United States

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Paducah, Kentucky, United States

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Detroit, Michigan, United States

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Edina, Minnesota, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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New Hyde Park, New York, United States

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Rochester, New York, United States

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Raleigh, North Carolina, United States

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Statesville, North Carolina, United States

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Cincinnati, Ohio, United States

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Delaware, Ohio, United States

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Mentor, Ohio, United States

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Eugene, Oregon, United States

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Rapid City, South Dakota, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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San Antonio, Texas, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Richmond, Virginia, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Related Publications (5)

• Blevins T, Pullman J, Malloy J, Yan P, Taylor K, Schulteis C, Trautmann M, Porter L. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011 May;96(5):1301-10. doi: 10.1210/jc.2010-2081. Epub 2011 Feb 9.

  PMID: 21307137 RESULT

• Blevins T, Ruggles J, Hardy E. Onset of Glycemic and Weight Outcomes in Patients Initiating Exenatide Once Weekly: The Relationship of Exenatide Exposure with Efficacy over the First 24 Weeks of Treatment. Diabetes Ther. 2016 Jun;7(2):361-8. doi: 10.1007/s13300-016-0172-0. Epub 2016 May 5.

  PMID: 27146799 DERIVED

• Grimm 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: 23748506 DERIVED

• Peyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125.

  PMID: 23039868 DERIVED

• Fineman 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: 22236356 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Peter Ohman, Medical Science Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Lisa Porter, MD

  Amylin Pharmaceuticals, LLC.

  STUDY DIRECTOR

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: April 6, 2009
• First Posted: April 8, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: April 7, 2015
• Results First Posted: June 19, 2012

Record last verified: 2015-03

Locations

US (41)