Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Official Title

Efficacy of Exenatide Compared with Insulin Glargine in Patients with Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy

Conditions

Type 2 diabetes mellitus

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Further Details

Study Start

Eligibility & Criteria

Ages Eligible for Study: 30 Years and aboveGenders Eligible for Study: Both Main Inclusion Criteria:- Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to – screening. – HbA1c between 7.1% and 11.0%, inclusive. – Insulin therapy should be the next appropriate step of diabetes treatment. – Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2. Main Exclusion Criteria:- Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs. - Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

Total Enrolment

Contact Details

For Australian Recruiting please contact Lilly Clinical Trials Support Center 1-877-CTLILLY(1-877-285-4559)