October 29, 2007 |
October 29, 2007 |
May 2003 |
Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period. [ Time Frame: At end of treatment arm or 3 months. ] |
Same as current |
No Changes Posted |
- HbA1c [ Time Frame: 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 [ Time Frame: At end of treatment arm or 3 months. ]
- 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) [ Time Frame: 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 [ Time Frame: At end of treatment arm or 3 months. ]
- The mean amplitude of glycemic excursion [ Time Frame: At end of treatment arm or 3 months. ]
- Concentration of plasma triglycerides and free fatty acids [ Time Frame: 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 [ Time Frame: At end of treatment arm or 3 months. ]
- Insulin dose and body weight [ Time Frame: At end of treatment arm or 3 months. ]
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Same as current |
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24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine |
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 |
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. |
Phase IV |
Interventional |
Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
Type 2 Diabetes |
- Drug: Lispro mix 75/25
- Drug: Glargine
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- Active Comparator: Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
- Active Comparator: Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.
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Completed |
15 |
December 2004 |
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Inclusion Criteria:
Exclusion Criteria:
- Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
- Are currently treated with a meglitinide without sulfonylurea
- Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
- Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory
- Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1
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Both |
21 Years to 80 Years |
No |
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United States |
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NCT00551538 |
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F3Z-MC-IOOM |
Eli Lilly and Company |
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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 |
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Eli Lilly and Company |
October 2007 |