Who is sponsoring NCT00191464?

NCT00191464 is sponsored by Eli Lilly and Company.

What condition does NCT00191464 study?

NCT00191464 studies Diabetes Mellitus, Type 2.

What drugs are being tested in NCT00191464?

Interventions: premeal insulin lispro mixtures, insulin glargine, metformin.

What is the status of NCT00191464?

NCT00191464 is currently COMPLETED.

Last reviewed 2010-10-12 · How we verify

Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes: A Comparison of Premeal Insulin Lispro Mixtures to Once-Daily Insulin Glargine

NCT00191464 Phase 4 COMPLETED

The primary objective of this study is to show that a prandial insulin regimen, consisting of premeal insulin lispro "mid mixture" (or a combined regimen of insulin lispro "mid mixture" and insulin lispro "low mixture") plus metformin will result in significantly better overall glycemic control (lower HbA1c) at endpoint than once-daily insulin glargine plus metformin. Insulin lispro "mid mixture" consists of 50% insulin lispro and 50% NPL. Insulin lispro "low mixture" consists of 25% insulin lispro and 75% NPL. In a substudy of approximately 60 patients, additional data will be collected on markers associated with risk of atherosclerosis or cardiovascular disease in the context of a controlled, outpatient, high-fat test meal.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 4
Status	COMPLETED
Enrolment	320
Start date	2003-12
Completion	2005-09

Conditions

Diabetes Mellitus, Type 2

Interventions

premeal insulin lispro mixtures
insulin glargine
metformin

Primary outcomes

HbA1C

Countries

United States, Australia, Greece, India, Netherlands, Poland, Puerto Rico