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

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Lilly

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191178
4957
F3Z-MC-IOOC

Details and patient eligibility

About

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.

Sex

All

Ages

21 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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