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 - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00036504

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Insulin Lispro low mixture	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients New to Insulin Therapy Who Were Inadequately Controlled on Oral Agents

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin lispro

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment:	100
Study Start Date:	August 2001
Estimated Study Completion Date:	August 2002

Detailed Description:

The aim of the present study is to compare two treatments - LM twice daily plus metformin two or three times daily versus a long acting insulin comparator once daily plus metformin two or three times daily - in patients with type 2 diabetes who are currently using a regimen of one or more oral antihyperglycemic agents.

The primary objective of this study is to demonstrate that, in patients with type 2 diabetes who are new to insulin, hemoglobin A1c at endpoint will be lower after treatment with insulin lispro LM twice daily plus metformin than after treatment with a long acting insulin comparator once daily plus metformin.

This will be a multicenter, randomized, open-label, crossover study comparing twice-daily insulin lispro LM plus two- or three-times-daily metformin to a once-daily long acting insulin comparator plus two- or three-times-daily metformin in patients with type 2 diabetes who were receiving one or more oral antihyperglycemic agents without insulin prior to the study.

Following an 8 (+-2) week lead-in period consisting of treatment with NPH once daily at bedtime plus metformin two or three times daily, approximately 100 eligible patients will be randomized to one of two sequence groups, so that there are approximately 50 patients in each group. One group will receive 4 months of insulin lispro LM administered immediately before the morning and evening meals plus metformin two or three times daily followed by 4 months of a once-daily long acting insulin comparator at bedtime plus metformin two or three times daily. The other group will receive the reverse sequence.

Eligibility

Ages Eligible for Study:	30 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036504

Locations

United States, California

LaJolla, California, United States

Walnut Creek, California, United States
United States, Connecticut

New Britain, Connecticut, United States
United States, Florida

Longwood, Florida, United States
United States, Georgia

Atlanta, Georgia, United States

Fayetteville, Georgia, United States
United States, Idaho

Boise, Idaho, United States
United States, Illinois

Springfield, Illinois, United States
United States, New Jersey

Mt. Laurel, New Jersey, United States

New Brunswick, New Jersey, United States
United States, New York

Syracuse, New York, United States
United States, Tennessee

Chattanooga, Tennessee, United States
United States, Texas

Dallas, Texas, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

Study ID Numbers:	4050, F3Z-MC-IOND
Study First Received:	May 10, 2002
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00036504 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Diabetes mellitus, insulin deficiency, hyperglycemia

Additional relevant MeSH terms:

Insulin, Long-Acting
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Insulin LISPRO
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 09, 2009