Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Diabetes Mellitus, Type 2

• have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione [TZD]) without insulin, for at least 90 days prior to Visit 1

• glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%

• regularly consume a light breakfast (less than 15% of total daily calorie intake)

• capable and willing to follow the protocol

• give written consent

Exclusion Criteria:

• are taking a TZD whose country label does not allow in combination with insulin

• are taking any glucose-lowering agents (other than specified in the inclusion criteria above)

• have a body mass index greater than 40 kg/m^2

• have a history of severe hypoglycemia in past 24 weeks

• are pregnant or may become pregnant

• women who are breastfeeding

• have significant cardiac disease

• have significant renal or liver disease

• undergoing therapy for a malignancy

• contraindications to study medications

• have an irregular sleep/wake cycle