Veterans Inpatient Insulin Study and Transition to Outpatient Therapy

NCT00821795 | Completed Phase 4 Results

• 1 other identifier: VIISTA-596-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 2; insulin; therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Hemoglobin A1c

  16 weeks

Secondary Outcomes (4)

• Seven Point Blood Glucose Profiles

  2 weeks

• Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control

  16 weeks

• Hypoglycemia

  daily

• Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter

  daily

Study Arms (2)

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

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

Interventions

NPH/Regular 70/30 mix DRUG

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

Also known as: Novolin 70/30

NPH/Regular 70/30 mix

insulin aspart protamine/insulin aspart 70/30 mix DRUG

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

Also known as: Novolog Mix 70/30

Aspart insulin analog biphasic mix

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dennis G. Karounos, M.D.: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

VA Medical Center - Lexington 596

Lexington, Kentucky, 40502, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Limitations and Caveats

The study is confined to Veterans requiring hospital admission for an acute medical illness on a general medicine ward with our study population being predominately elderly males greater than sixty years of age.

Results Point of Contact

• Title: Dennis G Karounos, MD Principal investigator
• Organization: Lexington VAMC

dennis.karounos@va.gov

859 233-4511

Study Officials

• Dennis G Karounos, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Endocrinology Section, Staff Physician

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: March 11, 2009
• Primary Completion: April 23, 2013
• Study Completion: April 23, 2013
• Last Updated: March 4, 2020
• Results First Posted: March 4, 2020

Record last verified: 2020-02

Locations

US (1)