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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IOOC |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin lispro protamine suspension:insulin lispro rDNA origin low mix | Drug | |||
| insulin glargine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17473060 | Result | 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. doi: 10.2337/dc06-2480. Epub 2007 May 1. No abstract available. | |
| 19940224 | Derived | Cox DJ, Ford D, Gonder-Frederick L, Clarke W, Mazze R, Weinger K, Ritterband L. Driving mishaps among individuals with type 1 diabetes: a prospective study. Diabetes Care. 2009 Dec;32(12):2177-80. doi: 10.2337/dc08-1510. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 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 |
| United States |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |