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Diabetes Mellitus, Type 2Phase 3NCT00082381

Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

A Phase 3 study testing Exenatide (AC2993) and Insulin glargine in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 91 sites in 13 countries.

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 is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c). Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Exenatide (AC2993) and Insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
551 participants
Where
91 sitesin 13 countries
Study dates
Jun 2003to Jul 2008
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients have been treated with a stable dose of one of the following for at least 3 months prior to screening: 1. 1500 to 2550 mg/day immediate-release metformin (or 1500 to 2000 mg/day extended-release metformin) and at least an optimally effective dose of a sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the same sulfonylurea and metformin requirements as for the individual components.
  • HbA1c between 7.0% and 10.0%, inclusive.
  • History of stable body weight (not varying by >10% for at least three months prior to screening).
  • Female patients are not breastfeeding, and female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause)

Who cannot join

  • Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
  • Patients are employed by Lilly or Amylin.
  • Patients have participated in this study previously or any other study using AC2993 or GLP-1 analogs.
  • Patients have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
  • Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening.
  • Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.
Show all 16Show fewer
  • Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria.
  • Patients have a known allergy or hypersensitivity to insulin glargine, AC2993, or excipients contained in these agents.
  • Patients have characteristics contraindicating metformin or sulfonylurea use, according to product-specific label, in the opinion of the investigator.
  • Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >=1.5 mg/dL for males and >=1.3 mg/dL for females.
  • Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamicpyruvic transaminase greater than three times the upper limit of the reference range.
  • Patients have known hemoglobinopathy or chronic anemia.
  • Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
  • Patients have used any prescription drug to promote weight loss within 3 months prior to screening.
  • Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator.
  • Patients fail to satisfy the investigator of suitability to participate for any other reason.

Trial locations and contacts

91 sites in 13 countries.

91 sites in 13 countries

United States21 sites

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • Israel Hartman, MD

    Arlington, Texas, 76014

  • Internal Medicine Associates Department of Research

    Fort Myers, Florida, 33901

  • Frederick Primary Care Associates

    Frederick, Maryland, 21702

  • Diabetes, Endocrine & Nutrition

    Hampton, New Hampshire, 03842

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Endocrinology Consultants of East Tennessee

    Knoxville, Tennessee, 37909

  • Lovelace Scientific Resources, Inc.

    Las Vegas, Nevada, 89102

  • Baptist Diabetes Associates

    Miami, Florida, 33176

  • Jack Wahlen, MD

    Ogden, Utah, 84403

  • Jon Shapiro, MD

    Philadelphia, Pennsylvania, 19146

  • Rainier Clinical Research Center, Inc.

    Renton, Washington, 98055

  • Diabetes & Glandular Research Associates, P.A.

    San Antonio, Texas, 78229

  • Radiant Research-San Diego

    San Diego, California, 92108

  • Dorothy L. and James E. Frank Diabetes Research Institute

    San Mateo, California, 94401

  • Springfield Diabetes & Endocrine Center

    Springfield, Illinois, 62704

  • Radiant Research, Inc.

    St Louis, Missouri, 63141

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

  • Great Lakes Medical Research

    Westfield, New York, 14787

  • Piedmont Medical Research Associates

    Winston-Salem, North Carolina, 27103

  • DOCS, Beth Israel Medical Center

    Yonkers, New York, 10710

Other trials in United States

Australia10 sites

  • Royal Adelaid Hospital

    Adelaid, South Australia, 5000

  • Eastern Health (Box Hill Hospital)

    Box Hill, Victoria, 3128

  • Royal Brisbane Hospital

    Brisbane, Queensland, 4029

  • Repatriation General Hospital

    Daw Park, South Australia, 5041

  • Freemantle Hospital

    Freemantle, Western Australia

  • SA Endocrine Clinical Research

    Keswick, South Australia, 5035

  • Australian Clinical Research Centre

    Miranda, New South Wales, 2228

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Clinical Trial and Research Unit

    Wollongong, New South Wales, 2500

Other trials in Australia

Germany8 sites

  • Diabetologische Schwerpunktpraxis

    Aschaffenburg, 63739

  • Diabetologische Scherpunktpraxis

    Bosenheim, 55545

  • Diabetologische Schwerpunktpraxis

    Dortmund, 44137

  • Krankenhaus Bethanien

    Hamburg, 20251

  • Universitatskliniken des Saarlandes

    Homburg/Saar, 66421

  • IKFE GmbH

    Mainz

  • Profil Institut fur Stoffwechselforschung GmbH

    Neuss

  • Diabetologische Schwerpunktpraxis

    Neuwied, 56564

Other trials in Germany

Poland8 sites

  • Bydgoskie Centrum Diabetologii i Endokrynologii

    Bydgoszcz, 85-822

  • Oddzial Chorob Wewnetrznych

    Częstochowa, 42-200

  • NZOZ "Diab-Endo-Met"

    Krakow

  • Poradnia Diabetologiczna

    Lodz, Rzgowska 281/289

  • Poradnia Diabetologiczna

    Lublin, 20-718

  • Oddzial Chorob Wewnetrznych

    Mielec, 39-300

  • Oddzial Chorob Wewnetrznych i Diabetologii

    Warsaw, 02-507

  • Wojewodzka Poradnia dla Chorych na Cukrzyce

    Warsaw, 03-242

Other trials in Poland

Belgium6 sites

  • UZ Antwerpen

    Endegem, 2650

  • UZ Gent

    Ghent, 9000

  • UZ Gasthuisberg

    Leuven, 3000

  • CHU Sart Tilman

    Liège, 4000

  • A.Z. Jan Palfijn

    Merksem, 2170

  • Sint Niklaasstraat

    Sint-Gillis-Waas, 9170

Other trials in Belgium

Puerto Rico6 sites

  • Universidad Central del Caribe

    Bayamón, 00956

  • Hospital Alejandro Otero Lopez

    Manati, 00674

  • Dr. Luis Ruiz

    Ponce, 00733

  • RCMI-Clinical Research Center

    Rio Piedras, 00935

  • San Juan Health Center

    San Juan, 00936-3833

  • Centro de Endocrinologia del Este

    Yabucoa, 00767

Other trials in Puerto Rico

Sweden6 sites

  • Lundberglaboratoriet for diabetesforskning

    Gothenburg, 413 45

  • Medicinska kliniken

    Helsingborg, 251 87

  • Kliniska Forskningsenheren

    Lund, 221 85

  • Diabetesmottagningen, Intermedicinska kliniken

    Stockholm, 118 83

  • CME, M71

    Stockholm, 141 86

  • Enheten for metabol kontroll

    Stockholm, 171 76

Other trials in Sweden

Netherlands5 sites

  • Diabetes Centrum Bilthoven

    Bilthoven, 3723 MB

  • Atrium Medisch Centrum Brunssum

    Brunssum, 6422 BE

  • Sint Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM

  • Refaja ziekenhuis

    Stadskanaal, 9501 HE

  • Medisch Centrum

    Westeinde

Other trials in Netherlands

Norway5 sites

  • Markeveien Spesialistpraksis

    Bergen, 5012

  • Spesiallegetjenesten AS

    Jessheim, 2050

  • Betanien Spesialistsenter

    Oslo, 0172

  • Sykehuset Asker of Baerum HF

    Rud, 1309

  • Forskningsstiftelsen Hjertelaget

    Stravanger, 4011

Other trials in Norway

Spain5 sites

  • Hospital Vega Baja

    Alicante, 03300

  • Hospital Doce de Octubre

    Madrid, 28041

  • Hospital Gral de Mostoles

    Madrid, 28934 Mostoles

  • Hospital Virgen de Valme

    Seville, 41014

  • Hospital la Ribera, Alzira

    Valencia, 46600 Alzira

Other trials in Spain

Brazil4 sites

  • Hospital Nossa Senhora das Gracas

    Curitiba, PR 80810-990

  • Centro Integrado de Diabetes e Hipertensao

    Fortaleza, CE 601200-020

  • Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas/HUWC/UFC

    Fortaleza, CE 60430-350

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, RS 90020-090

Other trials in Brazil

Portugal4 sites

  • Hospital Garcia de Orta-Servico de Endocrinologia

    Almada, 2805-267

  • Centro Hospitalar de Coimbra

    Coimbra, 3040-853

  • Associacao Protectora dos Diabeticos de Portugal

    Lisbon, 1250-203

  • Hospital Geral de Santo Antonio

    Porto, 4099-001

Other trials in Portugal

Finland3 sites

  • Eiran Sairaala c/o9 Clires

    Helsinki

  • Torikeskuksen Laakariasema, Yliopistonkatu

    Jyväskylä

  • Oulu Deakoness Institution

    Oulu, 90100

Other trials in Finland

About this study

Official title: Effect of AC2993 (Synthetic Exendin-4) Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).

Being tested
Exenatide (AC2993), Insulin glargine
Keywords
Diabetes, Insulin glargine, comparator, 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.

  • Exenatide (AC2993)Drug

    Also called Byetta

    subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks

  • Insulin glargineDrug

    Also called Lantus

    subcutaneous injection, once daily; forced titration to target blood glucose level

Study groups in NCT00082381
Study groupRoleWhat they receive
Exenatide ArmExperimentalexenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
Receives: Drug: Exenatide (AC2993)
Insulin Glargine ArmActive comparatorsubcutaneous injection, once daily; forced titration to target blood glucose level
Receives: Drug: Insulin glargine

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 week 26

    Measured: Baseline, week 26

Secondary outcomes (6)

  1. Percentage of Patients Achieving HbA1c <=7%

    Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 26 (percentage = [number of subjects with HbA1c <=7% at week 26 divided by number of subjects with HbA1c >7% at baseline] * 100%).

    Measured: 26 weeks

  2. Change in Body Weight

    Change in body weight from baseline to week 26

    Measured: Baseline, week 26

  3. Change in Fasting Serum Glucose

    Change in fasting serum glucose from baseline to week 26

    Measured: Baseline, week 26

  4. Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

    Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26

    Measured: Baseline, week 26

  5. Percentage of Patients With Hypoglycemic Events

    Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study

    Measured: 26 weeks

  6. Change in Rate of Hypoglycemic Events

    Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26

    Measured: Baseline, week 26

Timeline

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

  1. First posted11 May 2004 (estimated)
  2. Study startJun 2003
  3. Primary completionJul 2008
  4. Study completionJul 2008

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
551 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082381
Sponsor's protocol ID
H8O-MC-GWAA
Status last verified
Mar 2015
First submitted
6 May 2004
Last updated
7 Apr 2015
Data monitoring committee
No

Publications

  • Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG; GWAA Study Group. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2005 Oct 18;143(8):559-69. doi: 10.7326/0003-4819-143-8-200510180-00006.

    PubMed 16230722

  • 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

  • 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 (AC2993) and Insulin glargine in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 91 sites in 13 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 4 inclusion and 16 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 91 sites in United States, Australia, Germany, Poland, Belgium and 8 more countries. 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 31 Jul 2013). 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, week 26). 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 NCT00082381, which also lists 3 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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