Clinical trial NCT00821795: Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
Official title: Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2
insulin
therapy
Lead sponsor: Lexington VA Medical Center
Sponsor class: FED
Collaborators: name: Novo Nordisk A/S
First posted: 2009-01-13
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes for duration of three-months or longer
* greater than or equal to 40 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 glucose log or 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.

Primary outcomes:
measure: 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.
timeFrame: 16 weeks
Secondary outcomes:
measure: Seven Point Blood Glucose Profiles
timeFrame: 2 weeks
measure: Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control
timeFrame: 16 weeks
measure: Hypoglycemia
timeFrame: daily
measure: Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter
timeFrame: daily
Other outcomes:
Locations:
city: Lexington
country: United States
facility: VA Medical Center - Lexington 596
state: Kentucky
Study officials:
affiliation: VA Medical Center Lexington, KY and University of Kentucky College of Medicine
name: Dennis G Karounos, MD
role: PRINCIPAL_INVESTIGATOR
References: