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Sponsors and Collaborators: |
Lexington VA Medical Center Novo Nordisk |
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Information provided by: | Lexington VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00821795 |
Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions:
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: NPH/Regular 70/30 mix Drug: insulin aspart protamine/insulin aspart 70/30 mix |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy |
Estimated Enrollment: | 120 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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NPH/Regular 70/30 mix: Active Comparator
transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness
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Drug: NPH/Regular 70/30 mix
injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration
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Aspart insulin analog biphasic mix: Active Comparator
transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness
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Drug: insulin aspart protamine/insulin aspart 70/30 mix
injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks
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By doing this study, we hope to learn the optimal way to use insulin therapy to treat individuals during a hospitalization for an illness as well as during the recovery phase of the illness for twenty-four weeks after discharge from the hospital.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda S Barber, RN, BSN | (859)233-4511 ext 4427 | linda.barber2@va.gov |
Contact: Janet Hibbard, BS | (859)233-4511 ext 4611 | jhibb2@uky.edu |
United States, Kentucky | |
VA Medical Center - Lexington 596 | Recruiting |
Lexington, Kentucky, United States, 40502 | |
Contact: Linda S Barber, RN, BSN 859-233-4511 ext 4427 linda.barber2@va.gov | |
Contact: Janet Hibbard, BS (859)233-4511 ext 4611 jhibb2@uky.edu | |
Principal Investigator: Dennis G Karounos, MD |
Principal Investigator: | Dennis G Karounos, MD | VA Medical Center Lexington, KY and University of Kentucky College of Medicine |
Responsible Party: | VA Medical Center Lexington, KY ( Dennis G. Karounos, M.D. ) |
Study ID Numbers: | VIISTA-596-1 |
Study First Received: | January 12, 2009 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00821795 History of Changes |
Health Authority: | United States: Federal Government |
Diabetes Mellitus, Type 2 insulin therapy |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Insulin, Asp(B28)- Diabetes Mellitus Endocrine System Diseases |
Protamines Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Insulin, Asp(B28)- |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |