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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IOOR |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humalog Mix 50 | Drug | |||
| Human Insulin Mix 50:50 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50 |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives of the study are: | ||
| Assess hemoglobin A1c (HbA1c) values at baseline and after treatment with insulin lispro mix 50/50. | ||
| Assess HbA1c values at baseline and after treatment with human insulin mix 50/50. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18657196 | Derived | Gao Y, Li G, Li Y, Guo X, Yuan G, Gong Q, Yan L, Zheng Y, Zhang J. Postprandial blood glucose response to a standard test meal in insulin-requiring patients with diabetes treated with insulin lispro mix 50 or human insulin mix 50. Int J Clin Pract. 2008 Sep;62(9):1344-51. doi: 10.1111/j.1742-1241.2008.01850.x. Epub 2008 Jul 24. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C557537 | isophane insulin, insulin lispro drug combination 50:50 |
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| To compare human insulin mix 50/50 with insulin lispro mix 50/50 with regard to |
| Effects on HbA1c values obtained at the end of each treatment period; |
| Effects on fasting blood glucose values obtained throughout the study; |
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |