Status:
COMPLETED
Effects of Insulin in Perceived Mood Symptoms in Patients With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
21-79 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00191178
Start Date
August 1 2003
End Date
July 1 2005
Last Update
October 13 2010
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Charlottesville, Virginia, United States