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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191178
First received: September 12, 2005
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: insulin lispro protamine suspension:insulin lispro rDNA origin low mix
Drug: insulin glargine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: August 2003
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   21 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191178

Locations
United States, Virginia
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00191178     History of Changes
Other Study ID Numbers: 4957, F3Z-MC-IOOC
Study First Received: September 12, 2005
Last Updated: October 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Glargine
Insulin
Insulin, Long-Acting
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014