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

Lilly

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: insulin glargine

Drug: insulin lispro protamine suspension:insulin lispro rDNA origin low mix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191178

4957

F3Z-MC-IOOC

Details and patient eligibility

About

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.

Sex

All

Ages

21 to 79 years old

Volunteers

No Healthy Volunteers

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