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Type 2 Diabetes MellitusPhase 3NCT00603239

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

A Phase 3 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 25 sites in 5 countries.

Completed

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

Official record
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Trial summary

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
25 sitesin 5 countries
Study dates
Jan 2008to Jul 2009
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

  • Diagnosed with type 2 diabetes
  • If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
  • The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
  • The metformin dose has been stable for at least 90 days
  • Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
  • Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.

Who cannot join

  • Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
  • Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
  • Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.
  • Are currently treated with any of the following excluded medications:
  • Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
Show all 11Show fewer
  • Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
  • Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
  • Pramlintide acetate injection within 3 months prior to screening
  • Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

United States7 sites

  • Research Site

    Birmingham, Alabama

  • Research Site

    Concord, California

  • Research Site

    Corvallis, Oregon

  • Research Site

    Denver, Colorado

  • Research Site

    Fresno, California

  • Research Site

    Las Vegas, Nevada

  • Research Site

    Mogadore, Ohio

Other trials in United States

Romania6 sites

  • Research Site

    Baia Mare

  • Research Site

    Brasov

  • Research Site

    Bucharest

  • Research Site

    Dolj

  • Research Site

    Iași

  • Research Site

    Suceava

Other trials in Romania

Canada5 sites

  • Research Site

    Ajax, Ontario

  • Research Site

    Cambridge, Ontario

  • Research Site

    New Westminster, British Columbia

  • Research Site

    Windsor, Ontario

  • Research Site

    Winnipeg, Manitoba

Other trials in Canada

Mexico5 sites

  • Research Site

    Celaya, Guanajuato

  • Research Site

    Chihuahua City, Chihuahua

  • Research Site

    Mexico City, Mexico City

  • Research Site

    Mexico City

  • Research Site

    Monterrey, Nuevo León

Other trials in Mexico

South Africa2 sites

  • Research Site

    Johannesburg

  • Research Site

    Pretoria

Other trials in South Africa

About this study

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

Being tested
exenatide, placebo
Keywords
diabetes, exenatide, metformin, thiazolidinedione, Byetta, Amylin, Lilly
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.

  • exenatideDrug

    Also called Byetta

    subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)

  • placeboDrug

    subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day

Study groups in NCT00603239
Study groupRoleWhat they receive
Exenatide twice daily (BID)ExperimentalNot described
Receives: Drug: exenatide
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. Change in Glycosylated Hemoglobin (HbA1c)

    Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)

    Measured: baseline and 26 weeks

Secondary outcomes (10)

  1. Percentage of Patients Achieving HbA1c <= 7%

    Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)

    Measured: 26 weeks

  2. Percentage of Patients Achieving HbA1c <= 6.5%

    Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)

    Measured: 26 weeks

  3. Change in Fasting Serum Glucose (FSG)

    Change in FSG from baseline to endpoint (26 weeks)

    Measured: baseline and 26 weeks

  4. Change in Body Weight

    Change in body weight from baseline to endpoint (26 weeks)

    Measured: baseline and 26 weeks

  5. Change in Waist Circumference

    Change in waist circumference from baseline to endpoint (26 weeks)

    Measured: baseline and 26 weeks

  6. Change in Beta-cell Function

    Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.

    Measured: baseline and 26 weeks

  7. Change in Insulin Sensitivity.

    Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).

    Measured: baseline and 26 weeks

  8. Number of Subjects Who Experienced an Episode of Minor Hypoglycemia

    Overall number of subjects who experienced an episode of minor hypoglycemia.

    Measured: 26 weeks

  9. Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score

    IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = "never true" to 5 = "always true."

    Measured: baseline and 26 weeks

  10. Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score

    EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.

    Measured: baseline and 26 weeks

Timeline

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

  1. First posted29 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJul 2009
  4. Study completionJul 2009

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
Double blind
Who is masked
Participant, Investigator
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00603239
Sponsor's protocol ID
H8O-MC-GWCG
Status last verified
Mar 2015
First submitted
17 Jan 2008
Last updated
7 Apr 2015
Data monitoring committee
No

Publications

  • Liutkus J, Rosas Guzman J, Norwood P, Pop L, Northrup J, Cao D, Trautmann M. A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin. Diabetes Obes Metab. 2010 Dec;12(12):1058-65. doi: 10.1111/j.1463-1326.2010.01251.x.

    PubMed 20977576

  • Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.

    PubMed 22913891

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 25 sites in 5 countries.

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 6 inclusion and 11 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 25 sites in United States, Romania, Canada, Mexico, South Africa. 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. Some participants in this study may receive a placebo. 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 2 Sep 2010). 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 Glycosylated Hemoglobin (HbA1c) (time frame: baseline and 26 weeks). 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 NCT00603239, which also lists 2 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.

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