Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID

NCT00082381

Run by

AstraZeneca

People needed

551

Starts

2003-06-01

Expected to finish

2008-07-01

Last updated by the study team

2015-04-07

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Dorothy L. and James E. Frank Diabetes Research Institute — San Mateo, California, United States
• Internal Medicine Associates Department of Research — Fort Myers, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Baptist Diabetes Associates — Miami, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Springfield Diabetes & Endocrine Center — Springfield, Illinois, United States
• Frederick Primary Care Associates — Frederick, Maryland, United States
• Radiant Research, Inc. — St Louis, Missouri, United States
• Lovelace Scientific Resources, Inc. — Las Vegas, Nevada, United States
• Diabetes, Endocrine & Nutrition — Hampton, New Hampshire, United States
• Lovelace Scientific Resources — Albuquerque, New Mexico, United States
• Great Lakes Medical Research — Westfield, New York, 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
• Diabetes & Glandular Research Associates, P.A. — San Antonio, Texas, United States
• Jack Wahlen, MD — Ogden, Utah, United States
• Rainier Clinical Research Center, Inc. — Renton, Washington, 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
• Radiant Research-San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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