A Study in Adults With Type 2 Diabetes

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Insulin Glargine

Criteria

Inclusion Criteria:

• Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification

• Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study

• Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent

• Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m^2)

Exclusion Criteria:

• Have significant liver, cardiac or gastrointestinal disease

• Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)

• Have an excessive resistance to insulin or hypersensitivity to Lantus

• Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study

• Have taken any other insulin other than Lantus within the past 30 days

• Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin