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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

September 12, 2005
October 12, 2010
August 2003
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00191178 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Effects of Insulin in Perceived Mood Symptoms in Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: insulin lispro protamine suspension:insulin lispro rDNA origin low mix
  • Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2005
Not Provided

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
Both
21 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00191178
4957, F3Z-MC-IOOC
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP