Expired Study
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Charlottesville, Virginia


Purpose:

This study investigates the influence of two different insulin regimens, twice-daily insulin lispro low mix (LM) and once-daily insulin glargine, on perceived physical, mood, and cognitive symptoms as well as cognitive-motor task performance in patients with type 2 diabetes.


Criteria:

Inclusion Criteria: - Diagnosed as having type 2 diabetes mellitus, as defined by the World Health Organization - Are being treated with metformin therapy alone, metformin therapy plus once-daily insulin, or metformin plus one or more other oral antihyperglycemic agents at the time of study entry - Female patients not breastfeeding and female patients of childbearing potential must test negative for pregnancy at time of study entry based on a urine pregnancy test and do not intend to become pregnant during the study and agree to use a reliable form of birth control during the study - Hemoglobin A1c greater than or equal to 7.0% and less than or equal to 10% within 3 months prior to visit 1 - Have given informed consent to participate in the study in accordance with local regulations Exclusion Criteria: - Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry - Have previously been diagnosed with clinical depression or have been treated with a central nervous system stimulant, antidepressant, antipsychotic, or anxiolytic agent within 30 days prior to study entry - Have a known allergy to insulin lispro low mixture, insulin glargine, metformin hydrochloride, or excipients contained in these products - Have known hypersensitivity or contraindication to metformin hydrochloride


NCT ID:

NCT00191178


Primary Contact:

Study Director
Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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