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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IOOM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications. |
|
| 2 | Active Comparator | Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lispro mix 75/25 | Drug | Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period. | At end of treatment arm or 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | At end of treatment arm or 3 months. | |
| 2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined | At end of treatment arm or 3 months. |
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Inclusion Criteria:
Have type 2 diabetes
Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1
Have used:
Are greater than or equal to 21 and less than 80 years of age
As determined by the investigator, are capable and willing to:
Exclusion Criteria:
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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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | 46202 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16842478 | Result | Roach P, Malone JK. Comparison of insulin lispro mixture 25/75 with insulin glargine during a 24-h standardized test-meal period in patients with Type 2 diabetes. Diabet Med. 2006 Jul;23(7):743-9. doi: 10.1111/j.1464-5491.2006.01895.x. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Glargine | Drug | SC injection, once-daily, given in conjunction with oral antidiabetic medications. |
|
| Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL) | At end of treatment arm or 3 months. |
| The number of patients with increased plasma glucose during the last 2 hours of each inpatient period | At end of treatment arm or 3 months. |
| The mean amplitude of glycemic excursion | At end of treatment arm or 3 months. |
| Concentration of plasma triglycerides and free fatty acids | At end of treatment arm or 3 months. |
| Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value | At end of treatment arm or 3 months. |
| Insulin dose and body weight | At end of treatment arm or 3 months. |
| United States |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |