CClinicalTrials.gg
Sign In
CompletedNCT00821795VIISTAUpdated Mar 4, 2020Results posted

Veterans Inpatient Insulin Study and Transition to Outpatient Therapy

A Phase 4 interventional study of NPH/Regular 70/30 mix and insulin aspart protamine/insulin aspart 70/30 mix in Type 2 Diabetes Mellitus, sponsored by Dennis G. Karounos, M.D.. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by Dennis G. Karounos, M.D. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Diabetes Mellitus, Type 2
  • insulin
  • therapy
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Dennis G. Karounos, M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugNPH/Regular 70/30 mix

    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

  • Druginsulin 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

    Also known as: Novolog Mix 70/30

06

What researchers measure

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

    Time frame: 16 weeks

Secondary outcomes

  1. Seven Point Blood Glucose Profiles

    mg/dl

    Time frame: 2 weeks

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

    Time frame: 16 weeks

  3. Hypoglycemia

    Time frame: daily

  4. Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter

    Time frame: daily

07

Results

Posted Mar 4, 2020
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.

Participant flow

Participant flow — Overall Study
MilestoneNPH/Regular 70/30 MixAspart Insulin Analog Biphasic Mix
Started5064
Completed4460
Not completed64

Outcome measures

PrimaryFor 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

Time frame:
16 weeks
Reported as:
Mean · % hemoglobin A1c
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 A1cNPH/Regular 70/30 MixAspart Insulin Analog Biphasic Mix
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.8.32 ± 1.58.35 ± 1.95
SecondarySeven Point Blood Glucose Profiles

mg/dl

Time frame:
2 weeks

Results for this outcome have not been posted.

SecondaryPatient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control
Time frame:
16 weeks

Results for this outcome have not been posted.

SecondaryHypoglycemia
Time frame:
daily

Results for this outcome have not been posted.

SecondaryTwice Daily Blood Glucose Monitoring Using Telehealth Transmitter
Time frame:
daily

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NPH/Regular 70/30 Mix—15/50 (30%)6/50 (12%)
Aspart Insulin Analog Biphasic Mix—10/64 (15.6%)9/64 (14.1%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventNPH/Regular 70/30 MixAspart Insulin Analog Biphasic Mix
Cardiovascular diseaseCardiac disorders7/506/64
Cerebral vascular diseaseVascular disorders1/500/64
GastrointestinalGastrointestinal disorders1/500/64
GenitourinaryRenal and urinary disorders1/500/64
HypoglycemiaMetabolism and nutrition disorders1/500/64
InfectionInfections and infestations1/500/64
Neurological diseaseNervous system disorders1/501/64
RashSkin and subcutaneous tissue disorders1/500/64
SurgerySurgical and medical procedures1/501/64
Pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/501/64
Most frequent other events
Most frequent other events
EventNPH/Regular 70/30 MixAspart Insulin Analog Biphasic Mix
Severe HypoglycemiaMetabolism and nutrition disorders6/509/64

Baseline characteristics

Age, Continuous
Age, Continuous(years)NPH/Regular 70/30 MixAspart Insulin Analog Biphasic MixTotal
Mean65.1 ± 962.8 ± 8.663.8 ± 8.8
Sex: Female, Male
Sex: Female, Male(Participants)NPH/Regular 70/30 MixAspart Insulin Analog Biphasic MixTotal
Female022
Male5062112
08

Study locations

1 site
  • VA Medical Center - Lexington 596
    Lexington, Kentucky 40502, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00821795
Lead sponsor
Dennis G. Karounos, M.D.
Collaborators
Novo Nordisk A/S
Responsible party
Dennis G. Karounos, M.D. (Chief, Endocrinology Section, Staff Physician, Lexington VA Medical Center) — Sponsor-investigator
First posted
Jan 13, 2009
Start date
Mar 11, 2009
Primary completion
Apr 23, 2013
Completion
Apr 23, 2013
Results posted
Mar 4, 2020
Last update
Mar 4, 2020

Study contacts

Dennis G Karounos, MD
principal investigator · VA Medical Center Lexington, KY and University of Kentucky College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Start the discussion