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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00191581 |
Purpose
The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 |
Drug: Humalog Mix 50 Drug: Human Insulin Mix 50:50 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of 2-Hour Postprandial Blood Glucose Excursion in Response to a Standard Test Meal in Insulin-Requiring Diabetic Patients Treated Twice Daily With Either Insulin Lispro Mix 50/50 or Human Insulin Mix 50/50 |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | April 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
{1] Have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.
[2] Receive a total daily dose of insulin >2 units/kg.
[3] Have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.
[4] Have a body mass index >35 kg/m2.
[5] Have serum creatinine > the upper limit of normal (ULN), as determined by a local laboratory.
Contacts and Locations| China | |
| 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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Beijing, China | |
| 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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Guangzhou, China | |
| 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 |
More Information
| Study ID Numbers: | 9537, F3Z-MC-IOOR |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 28, 2006 |
| ClinicalTrials.gov Identifier: | NCT00191581 History of Changes |
| Health Authority: | China: State Food and Drug Administration |
|
Metabolic Diseases Autoimmune Diseases Immune System Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Insulin LISPRO |
Insulin Pharmacologic Actions Hypoglycemic Agents Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |