Veterans Inpatient Insulin Study and Transition to Outpatient Therapy - Full Text View

Sponsors and Collaborators:	Lexington VA Medical Center Novo Nordisk
Information provided by:	Lexington VA Medical Center
ClinicalTrials.gov Identifier:	NCT00821795

Purpose

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:

To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital.
To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: NPH/Regular 70/30 mix Drug: insulin aspart protamine/insulin aspart 70/30 mix	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Protamine

U.S. FDA Resources

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

Further study details as provided by Lexington VA Medical Center:

Primary Outcome Measures:

For transition from inpatient to outpatient care, evaluate glycemic control in subjects randomized to receive 70/30 NPH/regular insulin or aspart analog 70/30 mix bid- main outcome will be HbA1c during transition outpatient therapy phase. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Seven point blood glucose profiles [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Patient-reported outcomes - diabetes symptom checklist to evaluate perception of diabetes control [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Hypoglycemia [ Time Frame: daily ] [ Designated as safety issue: Yes ]
twice daily blood glucose monitoring using telehealth transmitter [ Time Frame: daily ] [ Designated as safety issue: Yes ]

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
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	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
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	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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with type 2 diabetes for duration of three-months or longer
40-75 years of age
Written informed consent to participate in the study
Admitted for hospitalization at VA Medical Center Lexington, KY
Able and willing to do the following:
Use the insulin injection device provided to you as you are instructed
Check your blood sugar as instructed using the blood sugar monitor and send the results by a telephone transmitter provided to you for use during the study
Enter your information in a diary provided to you
You have an acute non-critical medical illness requiring inpatient hospitalization (at least 24 hour admission) with a blood glucose between 140 and 400 mg/dl.
You require further hospitalization after being released from intensive care unit for an acute illness

Exclusion Criteria:

Have developed a severe illness requiring treatment in an intensive care unit as determined by your admitting physician.
Are pregnant or intend to become pregnant during this study, or are a sexually active woman who could become pregnant and are not practicing a birth control method considered acceptable by your study doctor for preventing pregnancy.
Are a woman who is breastfeeding.
Have a history of heart disease that limits your physical activity
Have had a kidney transplant or are currently receiving kidney dialysis
Have history of cancer other than minor skin cancer.
Have had a blood transfusion or severe loss of blood in the past 3 months or have any disease of the blood system.
Are allergic or sensitive to study insulin.
Are currently receiving oral steroid therapy.
Are currently on any other investigational medications or investigational protocols
Have drug or alcohol abuse that in the investigator's opinion would cause the individual to be non-compliant.
Are poorly compliant with the currently prescribed diabetes regimen or self monitoring of blood glucose, as defined by the investigator.
Have a mental condition that renders you unable to understand the scope and possible consequences of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821795

Contacts

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

Locations

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

Sponsors and Collaborators

Lexington VA Medical Center

Novo Nordisk

Investigators

Principal Investigator:

Dennis G Karounos, MD

VA Medical Center Lexington, KY and University of Kentucky College of Medicine

More Information

No publications provided

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

Keywords provided by Lexington VA Medical Center:

Diabetes Mellitus, Type 2
insulin
therapy

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Protamines
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 06, 2009