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
|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.|
|ClinicalTrials.gov Identifier: NCT00036504|
Recruitment Status : Completed
First Posted : May 13, 2002
Last Update Posted : October 13, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Insulin Lispro low mixture||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2001|
|Study Completion Date :||August 2002|
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|Ages Eligible for Study:||30 Years to 79 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
|Other Study ID Numbers:||
|First Posted:||May 13, 2002 Key Record Dates|
|Last Update Posted:||October 13, 2010|
|Last Verified:||October 2010|
Diabetes mellitus, insulin deficiency, hyperglycemia
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs