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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191178
• Other study ID #: 4957
• Secondary ID: F3Z-MC-IOOC
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: October 12, 2010
• Start date: August 2003
• Est. completion date: July 2005

Study information

• Verified date: October 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

• insulin glargine

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cox DJ, McCall A, Kovatchev B, Sarwat S, Ilag LL, Tan MH. Effects of blood glucose rate of changes on perceived mood and cognitive symptoms in insulin-treated type 2 diabetes. Diabetes Care. 2007 Aug;30(8):2001-2. Epub 2007 May 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	specific measures of depression, according to the Beck Depression Inventory-II
Secondary	blood glucose rate of change;eight-point self-monitored blood glucose profile;episodes of hypoglycemia, including episodes of severe hypoglycemia