Type 2 Diabetes
Conditions
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.
Interventions
DRUGinsulin glargine
DRUGinsulin lispro protamine suspension:insulin lispro rDNA origin low mix
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
| 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 | — |
Countries
United States
Outcome results
None listed