Veterans Inpatient Insulin Study and Transition to Outpatient Therapy

NCT ID: NCT00821795

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-11
• Study Completion Date: 2013-04-23

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPH/Regular 70/30 mix

transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness

Group Type: ACTIVE_COMPARATOR

NPH/Regular 70/30 mix

Intervention Type: DRUG

injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration

Aspart insulin analog biphasic mix

transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness

Group Type: ACTIVE_COMPARATOR

insulin aspart protamine/insulin aspart 70/30 mix

Intervention Type: DRUG

injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks

Interventions

NPH/Regular 70/30 mix

injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Novolin 70/30; Novolog Mix 70/30

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Dennis G. Karounos, M.D.

FED

Sponsor Role: lead

Responsible Party

Dennis G. Karounos, M.D.

Chief, Endocrinology Section, Staff Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dennis G Karounos, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

VA Medical Center - Lexington 596

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

VIISTA-596-1

Identifier Type: -

Identifier Source: org_study_id