Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00082381
- Lead Sponsor
- AstraZeneca
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exenatide Arm Exenatide (AC2993) exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks Insulin Glargine Arm Insulin glargine subcutaneous injection, once daily; forced titration to target blood glucose level
- Primary Outcome Measures
Name Time Method Change in Glycosylated Hemoglobin (HbA1c) Baseline, week 26 Change in HbA1c from baseline to week 26
- Secondary Outcome Measures
Name Time Method Percentage of Patients Achieving HbA1c <=7% 26 weeks 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%).
Change in Body Weight Baseline, week 26 Change in body weight from baseline to week 26
Change in Fasting Serum Glucose Baseline, week 26 Change in fasting serum glucose from baseline to week 26
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile Baseline, week 26 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
Percentage of Patients With Hypoglycemic Events 26 weeks 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
Change in Rate of Hypoglycemic Events Baseline, week 26 Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26
Trial Locations
- Locations (87)
Internal Medicine Associates Department of Research
🇺🇸Fort Myers, Florida, United States
Diabetes Centrum Bilthoven
🇳🇱Bilthoven, Netherlands
Medisch Centrum
🇳🇱Westeinde, Netherlands
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Dorothy L. and James E. Frank Diabetes Research Institute
🇺🇸San Mateo, California, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Frederick Primary Care Associates
🇺🇸Frederick, Maryland, United States
Springfield Diabetes & Endocrine Center
🇺🇸Springfield, Illinois, United States
Radiant Research, Inc.
🇺🇸St. Louis, Missouri, United States
Diabetes, Endocrine & Nutrition
🇺🇸Hampton, New Hampshire, United States
Great Lakes Medical Research
🇺🇸Westfield, New York, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
DOCS, Beth Israel Medical Center
🇺🇸Yonkers, New York, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States
Jon Shapiro, MD
🇺🇸Philadelphia, Pennsylvania, United States
Endocrinology Consultants of East Tennessee
🇺🇸Knoxville, Tennessee, United States
Israel Hartman, MD
🇺🇸Arlington, Texas, United States
Jack Wahlen, MD
🇺🇸Ogden, Utah, United States
Australian Clinical Research Centre
🇦🇺Miranda, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Clinical Trial and Research Unit
🇦🇺Wollongong, New South Wales, Australia
Royal Brisbane Hospital
🇦🇺Brisbane, Queensland, Australia
SA Endocrine Clinical Research
🇦🇺Keswick, South Australia, Australia
Repatriation General Hospital
🇦🇺Daw Park, South Australia, Australia
Royal Adelaid Hospital
🇦🇺Adelaid, South Australia, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Freemantle Hospital
🇦🇺Freemantle, Western Australia, Australia
UZ Antwerpen
🇧🇪Endegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
CHU Sart Tilman
🇧🇪Liege, Belgium
Sint Niklaasstraat
🇧🇪Sint Gillis Waas, Belgium
Hospital Nossa Senhora das Gracas
🇧🇷Curitiba, Brazil
A.Z. Jan Palfijn
🇧🇪Merksem, Belgium
Centro Integrado de Diabetes e Hipertensao
🇧🇷Fortaleza, Brazil
Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas/HUWC/UFC
🇧🇷Fortaleza, Brazil
Eiran Sairaala c/o9 Clires
🇫🇮Helsinki, Finland
Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Diabetologische Schwerpunktpraxis
🇩🇪Neuwied, Germany
Diabetologische Scherpunktpraxis
🇩🇪Bosenheim, Germany
Atrium Medisch Centrum Brunssum
🇳🇱Brunssum, Netherlands
Krankenhaus Bethanien
🇩🇪Hamburg, Germany
Universitatskliniken des Saarlandes
🇩🇪Homburg/Saar, Germany
IKFE GmbH
🇩🇪Mainz, Germany
Profil Institut fur Stoffwechselforschung GmbH
🇩🇪Neuss, Germany
Sint Antonius Ziekenhuis Nieuwegein
🇳🇱Nieuwegein, Netherlands
Refaja ziekenhuis
🇳🇱Stadskanaal, Netherlands
Markeveien Spesialistpraksis
🇳🇴Bergen, Norway
Sykehuset Asker of Baerum HF
🇳🇴Rud, Norway
Forskningsstiftelsen Hjertelaget
🇳🇴Stravanger, Norway
Bydgoskie Centrum Diabetologii i Endokrynologii
🇵🇱Bydgoszcz, Poland
Oddzial Chorob Wewnetrznych
🇵🇱Mielec, Poland
Universidad Central del Caribe
🇵🇷Bayamon, Puerto Rico
NZOZ "Diab-Endo-Met"
🇵🇱Krakow, Poland
Poradnia Diabetologiczna
🇵🇱Lublin, Poland
Oddzial Chorob Wewnetrznych i Diabetologii
🇵🇱Warszawa, Poland
Associacao Protectora dos Diabeticos de Portugal
🇵🇹Lisboa, Portugal
Wojewodzka Poradnia dla Chorych na Cukrzyce
🇵🇱Warszawa, Poland
Hospital Geral de Santo Antonio
🇵🇹Porto, Portugal
Hospital Alejandro Otero Lopez
🇵🇷Manati, Puerto Rico
Dr. Luis Ruiz
🇵🇷Ponce, Puerto Rico
San Juan Health Center
🇵🇷San Juan, Puerto Rico
RCMI-Clinical Research Center
🇵🇷Rio Piedras, Puerto Rico
Hospital Vega Baja
🇪🇸Alicante, Spain
Centro de Endocrinologia del Este
🇵🇷Yabucoa, Puerto Rico
Hospital Doce de Octubre
🇪🇸Madrid, Spain
Hospital Gral de Mostoles
🇪🇸Madrid, Spain
Hospital Virgen de Valme
🇪🇸Sevilla, Spain
Lundberglaboratoriet for diabetesforskning
🇸🇪Goteborg, Sweden
Medicinska kliniken
🇸🇪Helsingborg, Sweden
Hospital la Ribera, Alzira
🇪🇸Valencia, Spain
Kliniska Forskningsenheren
🇸🇪Lund, Sweden
Diabetesmottagningen, Intermedicinska kliniken
🇸🇪Stockholm, Sweden
CME, M71
🇸🇪Stockholm, Sweden
Enheten for metabol kontroll
🇸🇪Stockholm, Sweden
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
Diabetes & Glandular Research Associates, P.A.
🇺🇸San Antonio, Texas, United States
Radiant Research-San Diego
🇺🇸San Diego, California, United States
Lovelace Scientific Resources, Inc.
🇺🇸Las Vegas, Nevada, United States
Eastern Health (Box Hill Hospital)
🇦🇺Box Hill, Victoria, Australia
Oulu Deakoness Institution
🇫🇮Oulu, Finland
Torikeskuksen Laakariasema, Yliopistonkatu
🇫🇮Jyvaskyla, Finland
Hospital Garcia de Orta-Servico de Endocrinologia
🇵🇹Almada, Portugal
Centro Hospitalar de Coimbra
🇵🇹Coimbra, Portugal
Betanien Spesialistsenter
🇳🇴Oslo, Norway
Spesiallegetjenesten AS
🇳🇴Jessheim, Norway
Rainier Clinical Research Center, Inc.
🇺🇸Renton, Washington, United States