| Trial ID: | L3859 |
| Source ID: | NCT00821795
|
| Associated Drug: |
Nph/Regular 70/30 Mix
|
| Title: |
Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
|
| Acronym: |
VIISTA
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00821795/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: NPH/Regular 70/30 mix|DRUG: insulin aspart protamine/insulin aspart 70/30 mix
|
| Outcome Measures: |
Primary: 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: Seven Point Blood Glucose Profiles, mg/dl, 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
|
| Sponsor/Collaborators: |
Sponsor: Dennis G. Karounos, M.D. | Collaborators: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-03-11
|
| Completion Date: |
2013-04-23
|
| Results First Posted: |
2020-03-04
|
| Last Update Posted: |
2020-03-04
|
| Locations: |
VA Medical Center - Lexington 596, Lexington, Kentucky, 40502, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00821795
|