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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:
ClinicalTrials.gov Identifier:
NCT00036504
First Posted: May 13, 2002
Last Update Posted: October 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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
Intervention Model: Crossover Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 10, 2002
First Posted: May 13, 2002
Last Update Posted: October 13, 2010
Last Verified: October 2010

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

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