Trial Outcomes & Findings for Simplified Insulin Regimen for the Elderly (NCT NCT03660553)
NCT ID: NCT03660553
Last Updated: 2023-12-12
Results Overview
The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
7 participants
Primary outcome timeframe
6 months
Results posted on
2023-12-12
Participant Flow
Participant milestones
| Measure |
Multiple Subcutaneous Injection (MSI)
Multiple Subcutaneous Injection (MSI) group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
Insulin Glargine: 0.20 units/kg body weight
Insulin Aspart: 0.20 units/kg body weight
Insulin Lispro: 0.20 units/kg body weight
|
Basal Insulin (BI)
Basal Insulin (BI) group will receive only one injection of insulin glargine in the morning.
Insulin Glargine: 0.40 units/kg body weight
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Simplified Insulin Regimen for the Elderly
Baseline characteristics by cohort
| Measure |
Multiple Subcutaneous Injection (MSI)
n=3 Participants
MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
Insulin Glargine: 0.20 units/kg body weight
Insulin Aspart: 0.20 units/kg body weight
Insulin Lispro: 0.20 units/kg body weight
|
Basal Insulin (BI)
n=4 Participants
BI group will receive only one injection of insulin glargine in the morning.
Insulin Glargine: 0.40 units/kg body weight
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
HbA1c
|
9.9 %
n=93 Participants
|
7.9 %
n=4 Participants
|
8.6 %
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group
Outcome measures
| Measure |
Multiple Subcutaneous Injection (MSI)
n=3 Participants
MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
Insulin Glargine: 0.20 units/kg body weight
Insulin Aspart: 0.20 units/kg body weight
Insulin Lispro: 0.20 units/kg body weight
|
Basal Insulin (BI)
n=4 Participants
BI group will receive only one injection of insulin glargine in the morning.
Insulin Glargine: 0.40 units/kg body weight
|
|---|---|---|
|
Hemoglobin A1c (HbA1c)
|
8.5 percentage of HbA1c
Interval 7.4 to 9.7
|
7.8 percentage of HbA1c
Interval 7.6 to 8.0
|
SECONDARY outcome
Timeframe: 6 monthsDefined as any reported blood glucose (BG) \<70 mg/dl will be compared between the two groups
Outcome measures
| Measure |
Multiple Subcutaneous Injection (MSI)
n=3 Participants
MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
Insulin Glargine: 0.20 units/kg body weight
Insulin Aspart: 0.20 units/kg body weight
Insulin Lispro: 0.20 units/kg body weight
|
Basal Insulin (BI)
n=4 Participants
BI group will receive only one injection of insulin glargine in the morning.
Insulin Glargine: 0.40 units/kg body weight
|
|---|---|---|
|
Incidence of Any Hypoglycemia
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsAny BG \<54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.
Outcome measures
| Measure |
Multiple Subcutaneous Injection (MSI)
n=3 Participants
MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.
Insulin Glargine: 0.20 units/kg body weight
Insulin Aspart: 0.20 units/kg body weight
Insulin Lispro: 0.20 units/kg body weight
|
Basal Insulin (BI)
n=4 Participants
BI group will receive only one injection of insulin glargine in the morning.
Insulin Glargine: 0.40 units/kg body weight
|
|---|---|---|
|
Incidence of Severe Hypoglycemia
|
0 participants
|
0 participants
|
Adverse Events
Multiple Subcutaneous Injection (MSI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Basal Insulin (BI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place