Trial Outcomes & Findings for Insulin Schemes for Type 2 Diabetes Control (NCT NCT03350984)
NCT ID: NCT03350984
Last Updated: 2021-12-06
Results Overview
To determine the differences in the mean daily blood glucose measured in mg/dl, between a basal-bolus scheme and NPH schemes of insulin measured by the mean daily blood glucose.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
75 participants
Primary outcome timeframe
Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 week
Results posted on
2021-12-06
Participant Flow
A total of 111 hospitalized DM2 patients not critical to the study were evaluated. Of these, 35 did not meet the inclusion criteria and the 75 included participants were randomized into two groups. The recruitment of patients began on November 2, 2017 and ended on June 1, 2018.
Within the basal-bolus group, 1 patient was eliminated before initiating the insulin regimen, presenting acute abdomen and requiring intensive therapy. Therefore, 36 patients will start treatment in the basal-bolus group and 39 patients in the NPH group.
Participant milestones
| Measure |
NPH Insulin Group
Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin
NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.
|
Glargine and Lispro Insulin Group
Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.
Intervention drug: Glargine and Lispro
Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
36
|
|
Overall Study
COMPLETED
|
31
|
28
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
NPH Insulin Group
Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin
NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.
|
Glargine and Lispro Insulin Group
Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.
Intervention drug: Glargine and Lispro
Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Insulin Schemes for Type 2 Diabetes Control
Baseline characteristics by cohort
| Measure |
NPH Insulin Group
n=39 Participants
Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin
NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.
|
Glargine and Lispro Insulin Group
n=36 Participants
Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.
Intervention drug: Glargine and Lispro
Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
|
Total
n=75 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
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
39 participants
n=5 Participants
|
36 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Central glucose
|
237.3 mg / dl
STANDARD_DEVIATION 73.1 • n=5 Participants
|
223.1 mg / dl
STANDARD_DEVIATION 67 • n=7 Participants
|
230.5 mg / dl
STANDARD_DEVIATION 70.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 weekTo determine the differences in the mean daily blood glucose measured in mg/dl, between a basal-bolus scheme and NPH schemes of insulin measured by the mean daily blood glucose.
Outcome measures
| Measure |
NPH Insulin Group
n=39 Participants
Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin
NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.
|
Glargine and Lispro Insulin Group
n=36 Participants
Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.
Intervention drug: Glargine and Lispro
Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
|
|---|---|---|
|
Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.
Fasting blood glucose
|
129.6 mg/dl
Standard Deviation 23.6
|
135 mg/dl
Standard Deviation 22.6
|
|
Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.
Postprandial glucose
|
155.4 mg/dl
Standard Deviation 29
|
156.2 mg/dl
Standard Deviation 27.2
|
|
Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.
Glucose in the early morning
|
127.4 mg/dl
Standard Deviation 26.6
|
136.2 mg/dl
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: Duration of hospital stay, up to 4 weeks.To measure the number of participants with mild and severe hypoglycemic events
Outcome measures
| Measure |
NPH Insulin Group
n=39 Participants
Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin
NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.
|
Glargine and Lispro Insulin Group
n=36 Participants
Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.
Intervention drug: Glargine and Lispro
Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
|
|---|---|---|
|
the Number of Participants With Mild and Severe Hypoglycemic Events
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: blood glucose was taken every day, up to 4 weeks.Sustained glycemic control were the number of participants who not had: discharged before sustained control, critical status suspension, death before control, bad attachment to the protocol, interruption due to more than 2 hypoglycemic events during their hospital stay.
Outcome measures
| Measure |
NPH Insulin Group
n=39 Participants
Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin
NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.
|
Glargine and Lispro Insulin Group
n=36 Participants
Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.
Intervention drug: Glargine and Lispro
Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
|
|---|---|---|
|
Number of Participants With Sustained Glycemic Control During Hospital Stay
|
30 Participants
|
20 Participants
|
Adverse Events
NPH Insulin Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 1 deaths
Glargine and Lispro Insulin Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NPH Insulin Group
n=39 participants at risk
Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin
NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.
|
Glargine and Lispro Insulin Group
n=36 participants at risk
Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.
Intervention drug: Glargine and Lispro
Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
|
|---|---|---|
|
Infections and infestations
Soft tissue infection
|
35.9%
14/39 • Number of events 14 • 4 weeks
|
25.0%
9/36 • Number of events 9 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/39 • 4 weeks
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.6%
1/39 • Number of events 1 • 4 weeks
|
0.00%
0/36 • 4 weeks
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/39 • 4 weeks
|
2.8%
1/36 • Number of events 1 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place