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).
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
- 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.
UZ Antwerpen, Endegem 2650, Belgium
UZ Gent, Gent 9000, Belgium
UZ Gasthuisberg, Leuven 3000, Belgium
CHU Sart Tilman, Liege 4000, Belgium
A.Z. Jan Palfijn, Merksem 2170, Belgium
Sint Niklaasstraat, Sint Gillis Waas 9170, Belgium
Hospital Nossa Senhora das Gracas, Curitiba PR 80810-990, Brazil
Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas/HUWC/UFC, Fortaleza CE 60430-350, Brazil
Centro Integrado de Diabetes e Hipertensao, Fortaleza CE 601200-020, Brazil
Santa Casa de Misericordia de Porto Alegre, Porto Alegre RS 90020-090, Brazil
Eiran Sairaala c/o9 Clires, Helsinki, Finland
Torikeskuksen Laakariasema, Yliopistonkatu, Jyvaskyla, Finland
Oulu Deakoness Institution, Oulu 90100, Finland
Diabetologische Schwerpunktpraxis, Aschaffenburg 63739, Germany
Diabetologische Scherpunktpraxis, Bosenheim 55545, Germany
Diabetologische Schwerpunktpraxis, Dortmund 44137, Germany
Krankenhaus Bethanien, Hamburg 20251, Germany
Universitatskliniken des Saarlandes, Homburg/Saar 66421, Germany
IKFE GmbH, Mainz, Germany
Profil Institut fur Stoffwechselforschung GmbH, Neuss, Germany
Diabetologische Schwerpunktpraxis, Neuwied 56564, Germany
Diabetes Centrum Bilthoven, Bilthoven 3723 MB, Netherlands
Atrium Medisch Centrum Brunssum, Brunssum 6422 BE, Netherlands
Sint Antonius Ziekenhuis Nieuwegein, Nieuwegein 3435 CM, Netherlands
Refaja ziekenhuis, Stadskanaal 9501 HE, Netherlands
Medisch Centrum, Westeinde, Netherlands
Markeveien Spesialistpraksis, Bergen 5012, Norway
Spesiallegetjenesten AS, Jessheim 2050, Norway
Betanien Spesialistsenter, Oslo 0172, Norway
Sykehuset Asker of Baerum HF, Rud 1309, Norway
Forskningsstiftelsen Hjertelaget, Stravanger 4011, Norway
Bydgoskie Centrum Diabetologii i Endokrynologii, Bydgoszcz 85-822, Poland
Oddzial Chorob Wewnetrznych, Czestochowa 42-200, Poland
NZOZ "Diab-Endo-Met", Krakow, Poland
Poradnia Diabetologiczna, Lodz Rzgowska 281/289, Poland
Poradnia Diabetologiczna, Lublin 20-718, Poland
Oddzial Chorob Wewnetrznych, Mielec 39-300, Poland
Oddzial Chorob Wewnetrznych i Diabetologii, Warszawa 02-507, Poland
Wojewodzka Poradnia dla Chorych na Cukrzyce, Warszawa 03-242, Poland
Hospital Garcia de Orta-Servico de Endocrinologia, Almada 2805-267, Portugal
Centro Hospitalar de Coimbra, Coimbra 3040-853, Portugal
Associacao Protectora dos Diabeticos de Portugal, Lisboa 1250-203, Portugal
Hospital Geral de Santo Antonio, Porto 4099-001, Portugal
Universidad Central del Caribe, Bayamon 00956, Puerto Rico
Hospital Alejandro Otero Lopez, Manati 00674, Puerto Rico
Dr. Luis Ruiz, Ponce 00733, Puerto Rico
RCMI-Clinical Research Center, Rio Piedras 00935, Puerto Rico
San Juan Health Center, San Juan 00936-3833, Puerto Rico
Centro de Endocrinologia del Este, Yabucoa 00767, Puerto Rico
Hospital Vega Baja, Alicante 03300, Spain
Hospital Doce de Octubre, Madrid 28041, Spain
Hospital Gral de Mostoles, Madrid 28934 Mostoles, Spain
Hospital Virgen de Valme, Sevilla 41014, Spain
Hospital la Ribera, Alzira, Valencia 46600 Alzira, Spain
Lundberglaboratoriet for diabetesforskning, Goteborg 413 45, Sweden
Medicinska kliniken, Helsingborg 251 87, Sweden
Kliniska Forskningsenheren, Lund 221 85, Sweden
CME, M71, Stockholm 141 86, Sweden
Diabetesmottagningen, Intermedicinska kliniken, Stockholm 118 83, Sweden
Enheten for metabol kontroll, Stockholm 171 76, Sweden
Radiant Research-San Diego, San Diego, California 92108, United States
Dorothy L. and James E. Frank Diabetes Research Institute, San Mateo, California 94401, United States
Internal Medicine Associates Department of Research, Fort Myers, Florida 33901, United States
Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States
Baptist Diabetes Associates, Miami, Florida 33176, United States
Metabolic Research Institute, Inc., West Palm Beach, Florida 33401, United States
Springfield Diabetes & Endocrine Center, Springfield, Illinois 62704, United States
Frederick Primary Care Associates, Frederick, Maryland 21702, United States
Radiant Research, Inc., St. Louis, Missouri 63141, United States
Lovelace Scientific Resources, Inc., Las Vegas, Nevada 89102, United States
Diabetes, Endocrine & Nutrition, Hampton, New Hampshire 03842, United States
Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States
Australian Clinical Research Centre, Miranda, New South Wales 2228, Australia
Royal North Shore Hospital, St. Leonards, New South Wales 2065, Australia
Clinical Trial and Research Unit, Wollongong, New South Wales 2500, Australia
Great Lakes Medical Research, Westfield, New York 14787, United States
DOCS, Beth Israel Medical Center, Yonkers, New York 10710, United States
Piedmont Medical Research Associates, Winston-Salem, North Carolina 27103, United States
Jon Shapiro, MD, Philadelphia, Pennsylvania 19146, United States
Royal Brisbane Hospital, Brisbane, Queensland 4029, Australia
Royal Adelaid Hospital, Adelaid, South Australia 5000, Australia
Repatriation General Hospital, Daw Park, South Australia 5041, Australia
SA Endocrine Clinical Research, Keswick, South Australia 5035, Australia
Endocrinology Consultants of East Tennessee, Knoxville, Tennessee 37909, United States
Israel Hartman, MD, Arlington, Texas 76014, United States
Diabetes & Glandular Research Associates, P.A., San Antonio, Texas 78229, United States
Jack Wahlen, MD, Ogden, Utah 84403, United States
Eastern Health (Box Hill Hospital), Box Hill, Victoria 3128, Australia
Royal Melbourne Hospital, Parkville, Victoria 3050, Australia
Rainier Clinical Research Center, Inc., Renton, Washington 98055, United States
Freemantle Hospital, Freemantle, Western Australia, Australia
