Effects of Insulin in Perceived Mood Symptoms in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Protamines

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