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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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Exenatide (AC2993) (Drug); Insulin glargine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Chief Medical Officer, MD, Study Director, Affiliation: Eli Lilly and Company

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Glycosylated Hemoglobin (HbA1c)

Secondary outcome:

Percentage of Patients Achieving HbA1c <=7%

Change in Body Weight

Change in Fasting Serum Glucose

Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

Percentage of Patients With Hypoglycemic Events

Change in Rate of Hypoglycemic Events

Eligibility

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

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 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.

Locations and Contacts

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

Additional Information

Starting date: June 2003
Last updated: March 19, 2015

Page last updated: August 23, 2015

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