Expired Study
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Indianapolis, Indiana 46202


Purpose:

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.


Study summary:

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.


Criteria:

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: - single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or - insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or - a combination of the above. - Are greater than or equal to 21 and less than 80 years of age - As determined by the investigator, are capable and willing to: - comply with their prescribed diet and medication regimen, - perform self blood glucose monitoring, - use the patient diary as required for this protocol, - participate in two 24 hour inpatient assessments 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


NCT ID:

NCT00551538


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 21, 2017

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