Trial Outcomes & Findings for Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes (NCT NCT02408120)
NCT ID: NCT02408120
Last Updated: 2023-09-28
Results Overview
Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
226 participants
Primary outcome timeframe
5 days (average time of discharge from the hospital)
Results posted on
2023-09-28
Participant Flow
A total of 226 subjects consented from October 2015 to December 2019. Two subjects withdrew or left the hospital prior to randomization.
Participant milestones
| Measure |
Insulin Aspart for BG > 140 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
112
|
|
Overall Study
COMPLETED
|
108
|
107
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Insulin Aspart for BG > 140 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Treatment Refusal
|
1
|
0
|
|
Overall Study
Received Steroids
|
1
|
1
|
|
Overall Study
Discharged same day
|
1
|
1
|
|
Overall Study
Did not receive insulin
|
1
|
2
|
Baseline Characteristics
Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
92 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=5 Participants
|
107 participants
n=7 Participants
|
215 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 days (average time of discharge from the hospital)Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Mean Daily BG Levels
|
172 mg/dL
Standard Deviation 38.2
|
173 mg/dL
Standard Deviation 43
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The blood glucose levels will be assessed prior to lunch using a glucose meter.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Mean Blood Glucose Levels Before Lunch
|
160 mg/dL
Standard Deviation 16
|
172 mg/dL
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The blood glucose levels will be assessed at bedtime using a glucose meter.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Mean Blood Glucose Levels at Bedtime
|
157 mg/dl
Standard Deviation 18
|
171 mg/dl
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The blood glucose levels will be assessed before dinner using a glucose meter.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Mean Blood Glucose Levels Before Dinner
|
151 mg/dL
Standard Deviation 19
|
160 mg/dL
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The number of occurrences of hypoglycemia (blood glucose levels \< 70 mg/dL) will be recorded.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Number of Hypoglycemia Events
|
16 number of events
|
15 number of events
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The number of occurrences of hyperglycemia (blood glucose levels \> 260 mg/dL) will be recorded.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Incidence of Hyperglycemia
|
45 number of events
|
42 number of events
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Number of Blood Glucose Readings Within 100-140 mg/dL Range
|
59 number of readings
|
57 number of readings
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The average number of days in the hospital for subjects will be calculated.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Average Number of Days of Hospital Stay
|
4 days
Interval 3.0 to 7.5
|
4 days
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The total number of subject deaths during hospital stay will be recorded.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Mortality
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury \[rise of serum creatinine \>0.5 mg/dL (or 50%) of baseline value\]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Number of Subjects That Experienced Hospital Complications
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 5 days (average time of discharge from the hospital)Daily dose of insulin will be recorded
Outcome measures
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 Participants
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Mean Daily Dose of Insulin
|
47 units/day
Standard Deviation 43
|
41 units/day
Standard Deviation 30
|
Adverse Events
Insulin Aspart for BG > 140 mg/dL
Serious events: 0 serious events
Other events: 11 other events
Deaths: 1 deaths
Insulin Aspart for BG > 260 mg/dL
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Aspart for BG > 140 mg/dL
n=108 participants at risk
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>140 mg/dL.
|
Insulin Aspart for BG > 260 mg/dL
n=107 participants at risk
Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels \>260 mg/dL.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.3%
10/108 • 1 week
|
10.3%
11/107 • 1 week
|
|
Infections and infestations
Infection
|
0.00%
0/108 • 1 week
|
0.93%
1/107 • 1 week
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.93%
1/108 • 1 week
|
0.00%
0/107 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place