VIISTA: Veterans Inpatient Insulin Study and Transition to Outpatient Therapy

• Sponsor: Dennis G. Karounos, M.D. (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00821795
• Collaborator: Novo Nordisk A/S (Industry)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 49.4
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: NPH/Regular 70/30 mix; Drug: insulin aspart protamine/insulin aspart 70/30 mix	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy
• Actual Study Start Date: Mar 11, 2009
• Actual Primary Completion Date: Apr 23, 2013
• Actual Study Completion Date: Apr 23, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	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; Other Names: Novolin 70/30
Active Comparator: 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	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; Other Names: Novolog Mix 70/30

Outcome Measures

Primary Outcome Measures

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. [16 weeks]

   Hemoglobin A1c

Secondary Outcome Measures

1. Seven Point Blood Glucose Profiles [2 weeks]

   mg/dl

2. Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control [16 weeks]

3. Hypoglycemia [daily]

4. Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter [daily]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center - Lexington 596	Lexington	Kentucky	United States	40502

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Dennis G Karounos, MD, VA Medical Center Lexington, KY and University of Kentucky College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dennis G. Karounos, M.D., Chief, Endocrinology Section, Staff Physician, Lexington VA Medical Center
• ClinicalTrials.gov Identifier: NCT00821795
• Other Study ID Numbers: VIISTA-596-1
• First Posted: Jan 13, 2009
• Last Update Posted: Mar 4, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Dennis G. Karounos, M.D., Chief, Endocrinology Section, Staff Physician, Lexington VA Medical Center: Diabetes Mellitus, Type 2; insulin; therapy
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin; Insulin Aspart; Protamines

Study Results

Participant Flow

Arm/Group Title	NPH/Regular 70/30 Mix	Aspart Insulin Analog Biphasic Mix
Arm/Group Description	transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration	transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness 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
Period Title: Overall Study
STARTED	50	64
COMPLETED	44	60
NOT COMPLETED	6	4

Baseline Characteristics

Arm/Group Title	NPH/Regular 70/30 Mix	Aspart Insulin Analog Biphasic Mix	Total
Arm/Group Description	transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration	transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness 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	Total of all reporting groups
Overall Participants	50	64	114
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.1 (9)	62.8 (8.6)	63.8 (8.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	2 3.1%	2 1.8%
Male	50 100%	62 96.9%	112 98.2%

Outcome Measures

1. Primary Outcome

Title	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.
Description	Hemoglobin A1c
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NPH/Regular 70/30 Mix	Aspart Insulin Analog Biphasic Mix
Arm/Group Description	transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration	transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness 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
Measure Participants	44	60
Mean (Standard Deviation) [% hemoglobin A1c]	8.32 (1.5)	8.35 (1.95)

2. Secondary Outcome

Title	Seven Point Blood Glucose Profiles
Description	mg/dl
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Hypoglycemia
Time Frame	daily

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter
Time Frame	daily

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	NPH/Regular 70/30 Mix		Aspart Insulin Analog Biphasic Mix
Arm/Group Description	transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration		transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness 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
All Cause Mortality
	NPH/Regular 70/30 Mix		Aspart Insulin Analog Biphasic Mix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NPH/Regular 70/30 Mix		Aspart Insulin Analog Biphasic Mix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/50 (30%)		10/64 (15.6%)
Cardiac disorders
Cardiovascular disease	7/50 (14%)	7	6/64 (9.4%)	6
Gastrointestinal disorders
Gastrointestinal	1/50 (2%)	1	0/64 (0%)	0
General disorders
Adverse reaction	0/50 (0%)	0	1/64 (1.6%)	1
Infections and infestations
Infection	1/50 (2%)	1	0/64 (0%)	0
Metabolism and nutrition disorders
Hypoglycemia	1/50 (2%)	1	0/64 (0%)	0
Nervous system disorders
Neurological disease	1/50 (2%)	1	1/64 (1.6%)	1
Renal and urinary disorders
Genitourinary	1/50 (2%)	1	0/64 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary disease	0/50 (0%)	0	1/64 (1.6%)	1
Skin and subcutaneous tissue disorders
Rash	1/50 (2%)	1	0/64 (0%)	0
Surgical and medical procedures
Surgery	1/50 (2%)	1	1/64 (1.6%)	1
Vascular disorders
Cerebral vascular disease	1/50 (2%)	1	0/64 (0%)	0
Other (Not Including Serious) Adverse Events
	NPH/Regular 70/30 Mix		Aspart Insulin Analog Biphasic Mix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/50 (12%)		9/64 (14.1%)
Metabolism and nutrition disorders
Severe Hypoglycemia	6/50 (12%)	6	9/64 (14.1%)	9

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.