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Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using 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: NCT00082407
  Purpose

This is a Phase 3, multicenter, open-label, comparator-controlled 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: Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

Resource links provided by NLM:


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

Estimated Enrollment: 526
  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 the following for at least 3 months prior to screening: 1. >=1500 mg/day immediate-release metformin or extended-release metformin and at least an optimally effective dose for brand of 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 11.0%, inclusive.
  • Patients have a body mass index >25kg/m2 and <40 kg/m2.
  • Female patients are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to continue using a reliable method of birth control

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 previously, in this or any other study, received exenatide or glucagon-like peptide-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 have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate 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 biphasic insulin aspart, exenatide, or excipients contained in these agents.
  • Patients have characteristics contraindicating metformin or sulfonylurea use, according to product-specific label.
  • Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >=1.5 mg/dL for males and >=1.2 mg/dL for females.
  • Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamic pyruvic transaminase greater than three times the upper limit of the reference range.
  • Patients have known hemoglobinopathy or chronic anemia.
  • Patients have active proliferative retinopathy or macular edema.
  • Patients are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility, including but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
  • 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 been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides.
  • 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: NCT00082407

  Hide Study Locations
Locations
Croatia
Klinicki bolnicki centar Zagreb-Rebro
Zagreb, Croatia, 10000
Klinica bolnica Dubrava
Zagreb, Croatia, 10000
Clinical Hospital Osijek
Osijek, Croatia, 31000
Opca bolnica "Sveti Duh"
Zagreb, Croatia, 10000
Germany
Dr. Thomas Behnke
Neuwied, Germany, 56564
Dr. Klaus Busch
Dortmund, Germany, 44137
Internistische Gemeinschaftspraxis
Augsburg, Germany, 86150
Dr. Bernd Donaubauer
Oschatz, Germany, 04758
Dr. Joerg Steindorf
Schkeuditz, Germany, 04435
Institut for diabetic research
Munich, Germany, 80804
Dr. Karlheinz Hehemann
Beckum, Germany, 59269
Dr. Jerzi Jasinski
Wiesbaden, Germany, 65183
Medical Clinic and Policlinic 3
Giessen, Germany, 35392
Diabetologische Schwerpunktpraxis
Hamburg, Germany, 21073
Marienhospital Osnabruck
Osnabruck, Germany, 49074
Profil, Institut fur Stoffwechselstorungen
Neuss, Germany, 41460
IKFE GmbH
Mainz, Germany, 55119
Greece
"Polyclinic" General Hospital of Athens
Athens, Greece, 10552
Diabetes Center
Athens, Greece, 11527
1st Internal Medicine Department "Papagergiou"
Thessaloniki, Greece, 56429
Department of Endocrinology
Athens, Greece, 10676
University Hospital of Patras
Patras, Greece, 26500
Italy
Instituto di Endocrinologia
Catania, Italy, 95124
Policlinico Univarsitario P. Giaccone
Palermo, Italy, 90127
Dipartimento di fisiopatologia clinica
Florence, Italy, 50134
U.O. Medicina Generale
Milan, Italy, 60-20132
Ospedale Civile di Padova
Padova, Italy, 35128
U.O. Universita di Malattie del Metabolismo e Diabetologia
Torino, Italy
Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands, 6815 AD
Maxima Medisch Centrum Location Eindhoven
Eindhoven, Netherlands, 5631 BM
Gelre Ziekenhuizen
Apeldoorn, Netherlands, 7300 DS
Portugal
Hospital de Santo Andre
Leiria, Portugal, 2410-197
Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000-076
Hospital Pedro Hispano
Matosinhos, Portugal, 4454-509
Associacao Protectora dos Diabeticos de Portugal
Lisboa, Portugal, 1250-203
Romania
Spitalul Judetean Brasov
Brasov, Romania, 500326
Institutul de Diabet
Bucuresti, Romania, 020475
Institutul de Diabet
Bucuresti, Romania, 020475
Spitalul Clinic nr. 1 Judetean
Judet Timis, Romania, 300723
Russian Federation
National Endocrinology Research Center
Moscow, Russian Federation, 117036
Medical Military Academy
St. Petersburg, Russian Federation, 198013
Moscow State Medical Stomatological
Moscow, Russian Federation, 123448
National Endocrinology Research Center
Moscow, Russian Federation, 117036
Setchenov Moscow Medical Academy
Moscow, Russian Federation, 119881
Hospital of St. Elizabeth's
St. Petersburg, Russian Federation, 193257
City Clinical Hospital #2
St. Petersburg, Russian Federation, 194354
Russian Medical Academy for Advanced Medical Studies, Ministry of Health
Moscow, Russian Federation, 125315
Slovenia
Splosna bolnisnica Maribor
Maribor, Slovenia, 2000
Univerzitetni klinicni center Ljubljana
Ljubljana, Slovenia, 1000
Spain
Endocrinology Service (Planta Baja)
Palma de Mallorca, Spain, 07198
Hospital Virgen de Valme
Sevilla, Spain, 41014
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital General de Teruel
Teruel, Spain, 44002
Hospital Vega Baja
Alicante, Spain, 03300
Hospital la Ribera Alzira
Valencia, Spain, 46600 Alzira
Taiwan
Veteran General Hospital-Taichung
Taichung, Taiwan, 407
Tzu Chi General Hospital
Hualien, Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500
Tri-Service General Hospital
Taipei, Taiwan
United Kingdom
The Michael White Center for Diabetes and Endocrinology
Hull, United Kingdom, HU3 2JZ
Diabetes Research, Ward 34, Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Colchester General Hospital
Colchester, United Kingdom, CO4 5JL
Wellcome Labs, Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH3 9YW
Diabetes Unit, Gladsone Centre, Maelor Hospital
Wrexham, United Kingdom, LL13 7TD
Diabetes Trial Unit OCDEM, Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Diabetes Unit, Blackburn Royal Infirmary
Blackburn, United Kingdom, BB2 3LR
Education Centre, James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Queens Medical Centre
Nottingham, United Kingdom, NG7 2UH
Clinical Sciences Centre
Liverpool, United Kingdom, L7 8XP
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Study ID Numbers: H8O-MC-GWAD
Study First Received: May 6, 2004
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00082407     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes
exendin
Amylin
Lilly
insulin aspart

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 27, 2009