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Type 2 Diabetes MellitusPhase 3NCT00099320

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

A Phase 3 study testing exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 51 sites in 3 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 is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone. Read more about this study

Who is it for?
Ages 21 to 75 years
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
182 participants
Where
51 sitesin 3 countries
Study dates
May 2004to Aug 2005
Phase
Phase 3
Are there results?
None posted in the registry

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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
  • HbA1c between 7.1% and 10.0%, inclusive.
  • Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Who cannot join

  • Patient previously in a study using exenatide or GLP-1 analogs.
  • Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
  • Treated with oral insulin within 3 months of screening.

Trial locations and contacts

51 sites in 3 countries.

51 sites in 3 countries

United States40 sites

  • Research Site

    Albany, New York

  • Research Site

    Albuquerque, New Mexico

  • Research Site

    Atlanta, Georgia

  • Research Site

    Baton Rouge, Louisiana

  • Research Site

    Birmingham, Alabama

  • Research Site

    Butte, Montana

  • Research Site

    Charleston, West Virginia

  • Research Site

    Chattanooga, Tennessee

  • Research Site

    Chicago, Illinois

  • Research Site

    Cleveland, Ohio

  • Research Site

    Dallas, Texas

  • Research Site

    Georgetown, Texas

  • Research Site

    Greenville, North Carolina

  • Research Site

    Greenville, South Carolina

  • Research Site

    Hialeah, Florida

  • Research Site

    Honolulu, Hawaii

  • Research Site

    Huntington, West Virginia

  • Research Site

    Idaho Falls, Idaho

  • Research Site

    Jacksonville, Florida

  • Research Site

    Kalamazoo, Michigan

  • Research Site

    Knoxville, Tennessee

  • Research Site

    La Jolla, California

  • Research Site

    McCook, Nebraska

  • Research Site

    Melbourne, Florida

  • Research Site

    New York, New York

  • Research Site

    North Platte, Nebraska

  • Research Site

    Olympia, Washington

  • Research Site

    Omaha, Nebraska

  • Research Site

    Princeton, New Jersey

  • Research Site

    Renton, Washington

  • Research Site

    Rochester, New York

  • Research Site

    San Antonio, Texas

  • Research Site

    San Mateo, California

  • Research Site

    Santa Barbara, California

  • Research Site

    Scottsbluff, Nebraska

  • Research Site

    Spring Valley, California

  • Research Site

    Tacoma, Washington

  • Research Site

    The Colony, Texas

  • Research Site

    Troy, Michigan

  • Research Site

    West Palm Beach, Florida

Other trials in United States

Canada6 sites

  • Research Site

    Calgary, Alberta

  • Research Site

    Dartmouth, Nova Scotia

  • Research Site

    London, Ontario

  • Research Site

    Montreal, Quebec

  • Research Site

    Toronto, Ontario

  • Research Site

    Vancouver, British Columbia

Other trials in Canada

Spain5 sites

  • Research Site

    Granada

  • Research Site

    Seville

  • Research Site

    Valencia

  • Research Site

    Valladolid

  • Research Site

    Zaragoza

Other trials in Spain

About this study

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Being tested
exenatide, Placebo
Keywords
exenatide, exendin-4, diabetes, 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, AC2993, synthetic exendin-4

    After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.

  • PlaceboDrug

    After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.

Study groups in NCT00099320
Study groupRoleWhat they receive
ExenatideExperimentalAfter a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen
Receives: Drug: exenatide
PlaceboPlacebo comparatorAfter a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.
Receives: Drug: Placebo

What is being measured

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

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between

    Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between

    Measured: Baseline, Week 4, Week 8, Week 12, Week 16

  2. Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose

    Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

    Measured: Baseline, Week 16

Secondary outcomes (5)

  1. Percentage of subjects reaching the target HbA1c (<7%)

    The percentage of subjects reaching the target HbA1c (<7%) will be summarized and compared by treatment

    Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

  2. Change in body weight from Baseline to Week 16

    Change in body weight (kg) from Baseline to Week 16

    Measured: Baseline, Week 16

  3. Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose

    Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

    Measured: Baseline, Week 16

  4. Changes in beta cell function and insulin sensitivity between Baseline and Week 16

    Changes in beta cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses and the proinsulin/insulin ratio Between Baseline and Week 16

    Measured: Baseline, Week 16

  5. Changes in lipids between Baseline and Week 16

    Changes from Baseline to Week 16 in serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL-C]

    Measured: Baseline, Week 16

Timeline

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

  1. First posted13 Dec 2004 (estimated)
  2. Study startMay 2004
  3. Primary completionAug 2005
  4. Study completionAug 2005

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
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00099320
Sponsor's protocol ID
H8O-MC-GWAP
Status last verified
Jan 2015
First submitted
10 Dec 2004
Last updated
23 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • Zinman B, Hoogwerf BJ, Duran Garcia S, Milton DR, Giaconia JM, Kim DD, Trautmann ME, Brodows RG. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Apr 3;146(7):477-85. doi: 10.7326/0003-4819-146-7-200704030-00003.

    PubMed 17404349

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 51 sites in 3 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 3 inclusion and 3 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Canada, Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between (time frame: Baseline, Week 4, Week 8, Week 12, Week 16). The study lists 2 primary outcomes in all. 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 NCT00099320, 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 23 Feb 2015.

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