AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3NCT00877890

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

A Phase 3 study testing exenatide once weekly and exenatide twice daily in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
exenatide once weekly and exenatide twice daily
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
41 sitesUnited States
Study dates
Mar 2009to Jan 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Research Site

    Artesia, California

  • Research Site

    Austin, Texas

  • Research Site

    Avon, Indiana

  • Research Site

    Birmingham, Alabama

  • Research Site

    Burke, Virginia

  • Research Site

    Butte, Montana

  • Research Site

    Chicago, Illinois

  • Research Site

    Cincinnati, Ohio

  • Research Site

    Concord, California

  • Research Site

    Corpus Christi, Texas

  • Research Site

    DeLand, Florida

  • Research Site

    Delaware, Ohio

  • Research Site

    Detroit, Michigan

  • Research Site

    Edina, Minnesota

  • Research Site

    Encino, California

  • Research Site

    Eugene, Oregon

  • Research Site

    Evansville, Indiana

  • Research Site

    Greenbrae, California

  • Research Site

    Hialeah, Florida

  • Research Site

    La Mesa, California

  • Research Site

    Lexington, Kentucky

  • Research Site

    Manassas, Virginia

  • Research Site

    Mentor, Ohio

  • Research Site

    Mesa, Arizona

  • Research Site

    Miami, Florida

  • Research Site

    New Hyde Park, New York

  • Research Site

    New Port Richey, Florida

  • Research Site

    Olympia, Washington

  • Research Site

    Paducah, Kentucky

  • Research Site

    Palm Harbor, Florida

  • Research Site

    Peoria, Arizona

  • Research Site

    Raleigh, North Carolina

  • Research Site

    Rapid City, South Dakota

  • Research Site

    Richmond, Virginia

  • Research Site

    Rochester, New York

  • Research Site

    San Antonio, Texas

  • Research Site

    Spokane, Washington

  • Research Site

    St Louis, Missouri

  • Research Site

    Statesville, North Carolina

  • Research Site

    Tacoma, Washington

  • Research Site

    Walnut Creek, California

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus

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.

Being tested
exenatide once weekly, exenatide twice daily
Keywords
diabetes, exenatide once weekly, Byetta, Amylin, Lilly, Bydureon
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exenatide once weeklyDrug

    Also called BYDUREON

    subcutaneous injection, 2.0mg, once a week

  • exenatide twice dailyDrug

    Also called BYETTA

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

Study groups in NCT00877890
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: exenatide once weekly
2Active comparatorNot described
Receives: Drug: exenatide twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c From Baseline to Week 24

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

    Measured: Day 1, Week 24

Secondary outcomes (12)

  1. Percentage of Subjects Achieving HbA1c Target of <7%

    Percentages of subjects achieving HbA1c target value of <7% at Week 24.

    Measured: Week 24

  2. Percentage of Subjects Achieving HbA1c Target of <=6.5%

    Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24.

    Measured: Week 24

  3. Change in Fasting Plasma Glucose From Baseline to Week 24

    Change in fasting plasma glucose from baseline (Day 1) to Week 24.

    Measured: Day 1, Week 24

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

    Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24.

    Measured: Week 24

  5. Change in Body Weight From Baseline to Week 24

    Change in body weight from baseline (Day 1) to Week 24.

    Measured: Day 1, Week 24

  6. Change in Sitting Systolic Blood Pressure From Baseline to Week 24

    Change in systolic blood pressure from baseline (Day 1) to Week 24.

    Measured: Day 1, Week 24

  7. Change in Sitting Diastolic Blood Pressure From Baseline to Week 24

    Change in diastolic blood pressure from baseline (Day 1) to Week 24.

    Measured: Day 1, Week 24

  8. Change in Total Cholesterol From Baseline to Week 24

    Change in total cholesterol from baseline (Day 1) to Week 24.

    Measured: Day 1, Week 24

  9. Change in High-density Lipoprotein (HDL) From Baseline to Week 24

    Change in HDL from baseline (Day 1) to Week 24.

    Measured: Day 1, Week 24

  10. Ratio of Triglycerides at Week 24 to Baseline

    Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

    Measured: Day 1, Week 24

  11. Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events

    The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.

    Measured: Day 1 to Week 24

  12. Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events

    The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.

    Measured: Day 1 to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionOct 2009
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00877890
Sponsor's protocol ID
BCB108 (DURATION-5)
Status last verified
Mar 2015
First submitted
6 Apr 2009
Last updated
7 Apr 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 21307137

  • 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.

    PubMed 27146799

  • 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.

    PubMed 23748506

  • 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.

    PubMed 23039868

  • 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.

    PubMed 22236356

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide once weekly and exenatide twice daily in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline to Week 24 (time frame: Day 1, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00877890, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in