Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without Insulin

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are to determine: 1. If patients taking insulin lispro LM with metformin will have better overall control of their blood sugar than patients taking a long acting insulin comparator with metformin. 2. If there is a difference in the way the two treatments affect blood sugar control before and after meals and at night. 3. If there is a difference in the insulin dose required with the two treatments. 4. If there is a difference in the numbers of times patients experience low blood sugar with the two treatments. 5. If there is a difference in the effect on patients's body weight.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Type 2 diabetes.

• At least 30 years old and less than 80 years old.

• Using oral agents without insulin for 30 days prior ot study.

• Willing to start insulin injections using a pen device.

• Keep a patient diary.

Exclusion Criteria:

• Undergoing therapy for cancers.

• History of renal transplant or receiving renal dialysis.

• Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.

• Women who are breastfeeding.

• Have been treated with a drug within the last 30 days that has not received regulatory approval.