Type 2 Diabetes MellitusPhase 4VIISTANCT00821795
Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
A Phase 4 study testing NPH/Regular 70/30 mix and insulin aspart protamine/insulin aspart 70/30 mix in people with Type 2 Diabetes Mellitus, run by Dennis G. Karounos, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- NPH/Regular 70/30 mix and insulin aspart protamine/insulin aspart 70/30 mix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2009to 23 Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center - Lexington 596
Lexington, Kentucky, 40502
About this study
Official title: Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- NPH/Regular 70/30 mix, insulin aspart protamine/insulin aspart 70/30 mix
- Keywords
- Diabetes Mellitus, Type 2, insulin, therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPH/Regular 70/30 mixDrug
Also called Novolin 70/30
injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration
insulin aspart protamine/insulin aspart 70/30 mixDrug
Also called Novolog Mix 70/30
injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: insulin aspart protamine/insulin aspart 70/30 mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (4)
Seven Point Blood Glucose Profiles
mg/dl
Measured: 2 weeks
Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control
Measured: 16 weeks
Hypoglycemia
Measured: daily
Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study start11 Mar 2009
- Primary completion23 Apr 2013
- Study completion23 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dennis G. Karounos, M.D.
- Sponsor type
- US federal agency
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Dennis G. Karounos, M.D., Lexington VA Medical Center
- Investigators
- Dennis G Karounos, MD, Principal investigator, VA Medical Center Lexington, KY and University of Kentucky College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821795
- Sponsor's protocol ID
- VIISTA-596-1
- Acronym
- VIISTA
- Status last verified
- Feb 2020
- First submitted
- 12 Jan 2009
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy
- ClinicalTrials.gov ID
- NCT00821795
- Acronym / sponsor ID
- VIISTA / VIISTA-596-1
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Type 2, insulin, therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dennis G. Karounos, M.D.US federal agency
- Collaborators
- Novo Nordisk A/S
- Study start
- 11 Mar 2009 (actual)
- Primary completion
- 23 Apr 2013 (actual)
- Study completion
- 23 Apr 2013 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Posted 4 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPH/Regular 70/30 mix | Active comparator | Drug: NPH/Regular 70/30 mixtransition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness |
| Aspart insulin analog biphasic mix | Active comparator | Drug: insulin aspart protamine/insulin aspart 70/30 mixtransition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPH/Regular 70/30 mixAlso: Novolin 70/30injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration | Drug | NPH/Regular 70/30 mix |
| insulin aspart protamine/insulin aspart 70/30 mixAlso: Novolog Mix 70/30injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks | Drug | Aspart insulin analog biphasic mix |
Primary outcome
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.
Time frame: 16 weeks
Hemoglobin A1c
4 secondary outcomes
Seven Point Blood Glucose Profiles
Time frame: 2 weeks
Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control
Time frame: 16 weeks
Hypoglycemia
Time frame: daily
Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter
Time frame: daily
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis G Karounos, MD principal investigator
VA Medical Center Lexington, KY and University of Kentucky College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NPH/Regular 70/30 mix and insulin aspart protamine/insulin aspart 70/30 mix in people with Type 2 Diabetes Mellitus, run by Dennis G. Karounos, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.