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Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin Clinical research trials and Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin. Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin  Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin
Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin
For Condition: Diabetes Mellitus, Type 2
Status: No longer recruiting
Sponsor(s): Amylin Pharmaceuticals , Eli Lilly and Company
Synopsis: This is a Phase 3, multicenter, open-label, comparator-controlled trial.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 30 Years/75 Years
Genders: Both
Protocol Entry 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 affilated 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 glutamicpyruvic 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.
Total Enrollment: 526
Location and Contact Information:
Opca bolnica "Sveti Duh"
Zagreb, , 10000
Croatia
Medical Clinic and Policlinic 3
Giessen, , 35392
Germany
Maxima Medisch Centrum Location Eindhoven
Eindhoven, , 5631 BM
Netherlands
Hospitais da Universidade de Coimbra
Coimbra, , 3000-076
Portugal
Splosna bolnisnica Maribor
MARIBOR, , 2000
Slovenia
Dr. Klaus Busch
Dortmund, , 44137
Germany
Dr. Jerzi Jasinski
Wiesbaden, , 65183
Germany
Department of Endocrinology
Athens, , 10676
Greece
Hospital Clinic i Provincial de Barcelona
Barcelona, , 08036
Spain
Endocrinology Service (Planta Baja)
Palma de Mallorca, , 07198
Spain
Education Centre, James Cook University Hospital
Middlesbrough, , TS4 3BW
United Kingdom
Dr. Thomas Behnke
Neuwied, , 56564
Germany
IKFE GmbH
Mainz, , 55119
Germany
Marienhospital Osnabruck
Osnabruck, , 49074
Germany
City Clinical Hospital #2
St Petersburg, , 194354
Russian Federation
Internistische Gemeinschaftspraxis
Augsburg, , 86150
Germany
University Hospital of Patras
Patras, , 26500
Greece
Hospital Vega Baja
Alicante, , 03300
Spain
"Polyclinic" General Hospital of Athens
Athens, , 10552
Greece
Institutul de Diabet
Bucuresti, , 020475
Romania
Diabetologische Schwerpunktpraxis
Hamburg, , 21073
Germany
Hospital Pedro Hispano
Matosinhos, , 4454-509
Portugal
Tri-Service General Hospital
Taipei, ,
Taiwan, Province of China
Klinicki bolnicki centar Zagreb-Rebro
Zagreb, , 10000
Croatia
Dr. Bernd Donaubauer
Oschatz, , 04758
Germany
Hospital la Ribera Alzira
Valencia, , 46600 Alzira
Spain
Diabetes Unit, Blackburn Royal Infirmary
Blackburn, , BB2 3LR
United Kingdom
1st Internal Medicine Department "Papagergiou"
THESSALONIKI, , 56429
Greece
Spitalul Judetean Brasov
Brasov, , 500326
Romania
Setchenov Moscow Medical Academy
Moscow, , 119881
Russian Federation
Instituto di Endocrinologia
Catania, , 95124
Italy
Hospital de Santo Andre
Leiria, , 2410-197
Portugal
National Endocrinology Research Center
Moscow, , 117036
Russian Federation
Univerzitetni klinicni center Ljubljana
LJUBLJANA, , 1000
Slovenia
Hospital General de Teruel
Teruel, , 44002
Spain
Klinica bolnica Dubrava
Zagreb, , 10000
Croatia
U.O. Medicina Generale
Milan, , 60-20132
Italy
Hospital of St. Elizabeth's
St Petersburg, , 193257
Russian Federation
Clinical Sciences Centre
Liverpool, , L7 8XP
United Kingdom
Policlinico Univarsitario P. Giaccone
Palermo, , 90127
Italy
Rijnstate Ziekenhuis
ARNHEM, , 6815 AD
Netherlands
Spitalul Clinic nr. 1 Judetean
Judet Timis, , 300723
Romania
Medical Military Academy
St Petersburg, , 198013
Russian Federation
Hospital Virgen de Valme
Sevilla, , 41014
Spain
Royal Infirmary of Edinburgh
Edinburgh, , EH3 9YW
United Kingdom
Wellcome Labs, Royal Victoria Infirmary
Newcastle upon Tyne, , NE1 4LP
United Kingdom
Clinical Hospital Osijek
Osijek, , 31000
Croatia
Institut for diabetic research
Munich, , 80804
Germany
U.O. Universita di Malattie del Metabolismo e Diabetologia
Torino, ,
Italy
Moscow State Medical Stomatological
Moscow, , 123448
Russian Federation
Veteran General Hospital-Taichung
Taichung, , 407
Taiwan, Province of China
The Michael White Center for Diabetes and Endocrinology
Hull, , HU3 2JZ
United Kingdom
Diabetes Unit, Gladsone Centre, Maelor Hospital
Wrexham, , LL13 7TD
United Kingdom
Dr. Karlheinz Hehemann
Beckum, , 59269
Germany
Profil, Institut fur Stoffwechselstorungen
Neuss, , 41460
Germany
Dipartimento di fisiopatologia clinica
Florence, , 50134
Italy
Gelre Ziekenhuizen
Apeldoorn, , 7300 DS
Netherlands
Changhua Christian Hospital
Changhua, , 500
Taiwan, Province of China
Diabetes Research, Ward 34, Birmingham Heartlands Hospital
Birmingham, , B9 5SS
United Kingdom
Dr. Joerg Steindorf
Schkeuditz, , 04435
Germany
Diabetes Center
Athens, , 11527
Greece
Institutul de Diabet
Bucuresti, , 020475
Romania
National Endocrinology Research Center
Moscow, , 117036
Russian Federation
Russian Medical Academy for Advanced Medical Studies, Ministry of Health
Moscow, , 125315
Russian Federation
Tzu Chi General Hospital
Hualien, ,
Taiwan, Province of China
Glasgow Royal Infirmary
Glasgow, , G4 0SF
United Kingdom
Diabetes Trial Unit OCDEM, Churchill Hospital
Oxford, , OX3 7LJ
United Kingdom
Queens Medical Centre
Nottingham, , NG7 2UH
United Kingdom
Ospedale Civile di Padova
Padova, , 35128
Italy
Associacao Protectora dos Diabeticos de Portugal
Lisboa, , 1250-203
Portugal
Colchester General Hospital
Colchester, , CO4 5JL
United Kingdom
Additional Information:
Study ID Numbers: H8O-MC-GWAD;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082407
Other Diabetes Mellitus, Type 2 Studies:
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2. Insulin Resistance and Insulin Secretion
3. Evaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model
4. Randomized Trial of Health Events Costs in Diabetic Blacks
5. Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
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Exenatide Compared with Twice-Daily Biphasic Insulin Aspart in Patients with Type 2 Diabetes Using Sulfonylurea and Metformin
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