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

Condition(s) targeted: Type 2 Diabetes

Intervention: insulin lispro protamine suspension:insulin lispro rDNA origin low mix (Drug); insulin glargine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Pilot Study Investigating the Effects of Insulin Lispro Low Mixture Therapy Compared With Insulin Glargine on Perceived Mood Symptoms in Patients With Type 2 Diabetes Mellitus

Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome:

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:

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

Minimum age: 21 Years. Maximum age: 79 Years. Gender(s): Both.

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

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

Starting date: August 2003
Ending date: July 2005
Last updated: July 28, 2006