ong-Term Treatment with Exenatide versus Glimepiride in Patients with Type 2 Diabetes Pretreated with Metformin - EUREXA

• Conditions: Patients present with type 2 diabetes based on the disease diagnostic; MedDRA version: 6.1Level: PTClassification code 10012613

• Registration Number: EUCTR2005-005448-21-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-23
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1054

Inclusion Criteria

Patients are between 18 and 85 years of age, inclusive//Patients present with type 2 diabetes based on the disease diagnostic criteria as defined by the World Health Organization WHO //patients have been treated with diet and exercise, and a stable, maximally tolerated dose in the opinion of the investigator of immediate-release metformin or extended-release metformin for at least 3 months prior to screening//Patients have suboptimal glycemic control as evidenced by an HbA1c between 6.5 and 9.0 , for whom a sulfonylurea treatment is deemed appropriate in the opinion of the investigator as a next step of diabetes treatment//Patients have a body mass index 25 kg/m2 and 40 kg/m2//Patients have a history of stable body weight not varying by 10 for at least 3 months prior to screening .
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

Exclusion Criteria

Patients have characteristics contraindicating metformin or glimepiride 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 132 mol/L for males and 1.2 mg/dL 110 mol/L for females // Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine aminotransaminase ALT , or serum glutamic pyruvic transaminase SGPT greater than three times the upper limit of the reference range // Patients have known hemoglobinopathy or clinically significant, chronic anemia // Patients have active, symptomatic proliferative retinopathy or macular edema // Patients are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility, including but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics // Patients have severe gastrointestinal disease, including gastroparesis // 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, Sulfonylurea, Meglitinides.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified