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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00551538 |
The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: Lispro mix 75/25 Drug: Glargine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Twenty-Four-Hour Plasma Glucose Profiles Observed in Patients With Type 2 Diabetes During Therapy Consisting of Oral Agent(s) Plus Twice-Daily Insulin Lispro Low Mixture or Once-Daily Insulin Glargine |
Enrollment: | 15 |
Study Start Date: | May 2003 |
Study Completion Date: | December 2004 |
Arms | Assigned Interventions |
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1: Active Comparator
Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
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Drug: Lispro mix 75/25
Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
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2: Active Comparator
Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.
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Drug: Glargine
SC injection, once-daily, given in conjunction with oral antidiabetic medications.
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The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have used:
As determined by the investigator, are capable and willing to:
Exclusion Criteria:
United States, Indiana | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Indianapolis, Indiana, United States, 46202 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Study ID Numbers: | 7505, F3Z-MC-IOOM |
Study First Received: | October 29, 2007 |
Last Updated: | October 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00551538 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diabetes Diabetic Insulin Glargine Lispro |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus Insulin LISPRO |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Glargine |
Diabetes Mellitus Insulin LISPRO Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |