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Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin
This study has been completed.
First Received: May 6, 2004   Last Updated: November 5, 2007   History of Changes
Sponsor: Amylin Pharmaceuticals, Inc.
Collaborator: Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00082381
  Purpose

This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: AC2993
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Resource links provided by NLM:


Further study details as provided by Amylin Pharmaceuticals, Inc.:

Estimated Enrollment: 500
Estimated Study Completion Date: July 2004
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 affilated 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082381

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

Additional Information:
Publications:
Study ID Numbers: H8O-MC-GWAA
Study First Received: May 6, 2004
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00082381     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
Diabetes
Insulin glargine
comparator
Amylin
Lilly

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 25, 2009