Trial Outcomes & Findings for Veterans Inpatient Insulin Study and Transition to Outpatient Therapy (NCT NCT00821795)
NCT ID: NCT00821795
Last Updated: 2020-03-04
Results Overview
Hemoglobin A1c
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
16 weeks
Results posted on
2020-03-04
Participant Flow
Participant milestones
| Measure |
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
NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration
|
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
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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
64
|
|
Overall Study
COMPLETED
|
44
|
60
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
Baseline characteristics by cohort
| Measure |
NPH/Regular 70/30 Mix
n=50 Participants
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
|
Aspart Insulin Analog Biphasic Mix
n=64 Participants
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
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 9 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksHemoglobin A1c
Outcome measures
| Measure |
NPH/Regular 70/30 Mix
n=44 Participants
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
|
Aspart Insulin Analog Biphasic Mix
n=60 Participants
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
|
|---|---|---|
|
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 % hemoglobin A1c
Standard Deviation 1.5
|
8.35 % hemoglobin A1c
Standard Deviation 1.95
|
SECONDARY outcome
Timeframe: 2 weeksmg/dl
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: dailyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: dailyOutcome measures
Outcome data not reported
Adverse Events
NPH/Regular 70/30 Mix
Serious events: 15 serious events
Other events: 6 other events
Deaths: 0 deaths
Aspart Insulin Analog Biphasic Mix
Serious events: 10 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NPH/Regular 70/30 Mix
n=50 participants at risk
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
|
Aspart Insulin Analog Biphasic Mix
n=64 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Cardiovascular disease
|
14.0%
7/50 • Number of events 7
|
9.4%
6/64 • Number of events 6
|
|
Vascular disorders
Cerebral vascular disease
|
2.0%
1/50 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.0%
1/50 • Number of events 1
|
0.00%
0/64
|
|
Renal and urinary disorders
Genitourinary
|
2.0%
1/50 • Number of events 1
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Infection
|
2.0%
1/50 • Number of events 1
|
0.00%
0/64
|
|
Nervous system disorders
Neurological disease
|
2.0%
1/50 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary disease
|
0.00%
0/50
|
1.6%
1/64 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • Number of events 1
|
0.00%
0/64
|
|
Surgical and medical procedures
Surgery
|
2.0%
1/50 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
General disorders
Adverse reaction
|
0.00%
0/50
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
NPH/Regular 70/30 Mix
n=50 participants at risk
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
|
Aspart Insulin Analog Biphasic Mix
n=64 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
Severe Hypoglycemia
|
12.0%
6/50 • Number of events 6
|
14.1%
9/64 • Number of events 9
|
Additional Information
Dennis G Karounos, MD Principal investigator
Lexington VAMC
Phone: 859 233-4511
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place