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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00036504
First received: May 10, 2002
Last updated: October 12, 2010
Last verified: October 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
ClinicalTrials.gov Identifier: NCT00036504     History of Changes
Other Study ID Numbers: 4050, F3Z-MC-IOND
Study First Received: May 10, 2002
Last Updated: October 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Diabetes mellitus, insulin deficiency, hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Insulin
Insulin Lispro
Insulin, Globin Zinc
Insulin, Long-Acting
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014