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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-ME-IOOL |
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In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.
The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications. |
|
| 1 | Active Comparator | Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin lispro mix 25 | Drug | Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast | 16 weeks or end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c measured at endpoint | 16 weeks or end of study. | |
| Change of hemoglobin A1c from baseline to endpoint | 16 weeks or end of study. | |
| Glycemic control as determined by self-monitored blood glucose concentrations |
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Inclusion Criteria:
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. | Mexico City |
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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 |
|---|---|
| C482266 | insulin lispro, isophane insulin lispro drug combination (25:75) |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Glargine | Drug | Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications. |
|
|
| 16 weeks or end of study. |
| The incidence and rate of self-reported hypoglycemic episodes | 16 weeks or end of study. |
| Body mass index (BMI) | 16 weeks or end of study. |
| Body weight | 16 weeks or end of study. |
| Total Insulin Doses | 16 weeks or end of study. |
| Mexico |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |