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

Completed · Phase 4

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00036504

Run by

Eli Lilly and Company

People needed

100

Starts

2001-08-01

Expected to finish

2002-08-01

Last updated by the study team

2010-10-13

Who can join

Age: 30 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — La Jolla, California, United States
• Study site — Walnut Creek, California, United States
• Study site — New Britain, Connecticut, United States
• Study site — Longwood, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Fayetteville, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Springfield, Illinois, United States
• Study site — Mount Laurel, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Syracuse, New York, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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