Effects of Insulin in Perceived Mood Symptoms in Patients With Type 2 Diabetes
Phase 4
Completed
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT00191178
- Lead Sponsor
- Eli Lilly and Company
- 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 well as cognitive-motor task performance in patients with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Compare twice-daily insulin lispro Low Mix therapy and once-daily insulin glargine therapy with respect to perceived mood on patient-rated questionnaires following chronic treatment administration in patients with type 2 diabetes Instruments used/tests performed:hand held computers to rate a series of 13 symptoms;hand held computers to administer a series of cognitive-motor performance tests;blood glucose testing
- Secondary Outcome Measures
Name Time Method physical energy level as reflected by subjective symptoms, self-report of activity level, and physical motion as reflected by a pedometer worn at the waist specific measures of depression, according to the Beck Depression Inventory-II blood glucose rate of change;eight-point self-monitored blood glucose profile;episodes of hypoglycemia, including episodes of severe hypoglycemia Compare insulin lispro Low Mix therapy and insulin glargine therapy with respect to:scores (collective and specific) on patient-rated mood, physical, and cognitive symptoms;scores on specific cognitive-motor performance tests
Trial Locations
- Locations (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