A Phase 3, randomized, open label, comparator-controlled, parallel-group, multicentre study to compare the effects of exenatide and insulin glargine on beta cell function and cardiovascular risk markers in subjects with Type 2 diabetes treated with metformin who have not achieved target HbA1c - 114

Eli Lilly and Company0 sites75 target enrollmentStarted: July 14, 2004Last updated: April 4, 2022

Conditions

Drugs

Trial Snapshot

No summary available.

•All individuals must satisfy all inclusion criteria unless appropriate approval is obtained.
•1.Is between 30 and 75 years of age, inclusive.
•2.Has an HbA1c of 6.6% to 9.5%, inclusive.
•3.Has a body mass index of 25 kg/m2 to 40 kg/m2, inclusive.
•4.Is male or if female, has a negative pregnancy test (human chorionic gonadotropin, ß subunit [ß hCG]) regardless of birth control method used and agrees to continue using birth control throughout the study to prevent pregnancy.
•5.Has a diagnosis of type 2 diabetes and is otherwise healthy.
•6.Has fasting (at least 8 h) plasma glucose <14.4 mmol/L (260 mg/dL).
•7.Has blood pressure <=165/95 mmHg measured in the sitting position.
•8.Has a physical examination and ECG at screening with no clinically significant abnormalities as judged by the investigator.
•9.Has been treated with a stable dose of metformin for at least 3 months prior to screening.
•10.Has a history of stable body weight (not varying by >10% for at least 3 months prior to screening).
•Open ended extension: completed initial study, off study drug for at least 8 weeks before starting extension.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Clinical significant history (organ transplant, hepatic, renal, CNS, GI, pulmonary, hematologic diseases including anemia, blood transplant, recent surgery, donated blood, low hemoglobin, CV problems)
•More than 3 episodes of severe hypoglycaemia within 6 months before screen
•Less than 2 years remission from clinical significant malignancy.
•Expresses apoE2 allele
•Known hypersensitivity to components of treatment
•Been in a previous exenatide study
•Taking excluded medications (insulin, SU, TZD, meglitinides, alpha glucosidase, gastrointestinal motility products, antineoplastics, weight loss agents, transplant medications, lipid lowering or b blockers, HRT) or any investigational drug.
•Received chronic systemic glucocorticoid therapy
•Relative to person affiliated with study
•Employee of Amylin or Lilly

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