Trial Outcomes & Findings for Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon (NCT NCT00694122)
NCT ID: NCT00694122
Last Updated: 2014-10-21
Results Overview
Cumulative sum of repeatedly measured blood glucose values (mg/dl) beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on neutral protamine Hagedorn (NPH) insulin as the long acting insulin; the other overnight was glargine (Lantus) insulin as the the long acting insulin.
COMPLETED
PHASE3
27 participants
Overnight
2014-10-21
Participant Flow
Recruitment began in January 2007 and ended on January 2011. Individuals were recruited from the MGH Diabetes Center, MGH internal Research Broadcast for research volunteers. Advertisements were placed in the local metro and flyers posted around the institution, altho no participants contacted study staff from these latter advertisemens.
200 participants were recruited; 43 were phone screened; 27 signed consent forms, 12 exluded (3 did not meet inclusion criteria, 7 no longer wanted to participate and 3 lost to follow-up).
Participant milestones
| Measure |
Lantus First, Then NPH
Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied
|
NPH First, Then Lantus
NPH was given twice per day in the first intervention period for 3-4 weeks and .Lantus was given once per day in second intervention period for 3-4 weeks.
|
|---|---|---|
|
First Intervention (3-4 Weeks)
STARTED
|
20
|
7
|
|
First Intervention (3-4 Weeks)
COMPLETED
|
10
|
5
|
|
First Intervention (3-4 Weeks)
NOT COMPLETED
|
10
|
2
|
|
Washout (1 Day)
STARTED
|
10
|
5
|
|
Washout (1 Day)
COMPLETED
|
10
|
5
|
|
Washout (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3-4 Weeks)
STARTED
|
10
|
5
|
|
Second Intervention (3-4 Weeks)
COMPLETED
|
10
|
5
|
|
Second Intervention (3-4 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lantus First, Then NPH
Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied
|
NPH First, Then Lantus
NPH was given twice per day in the first intervention period for 3-4 weeks and .Lantus was given once per day in second intervention period for 3-4 weeks.
|
|---|---|---|
|
First Intervention (3-4 Weeks)
Withdrawal by Subject
|
7
|
0
|
|
First Intervention (3-4 Weeks)
Lost to Follow-up
|
1
|
1
|
|
First Intervention (3-4 Weeks)
Did not meet entrance criteria
|
2
|
1
|
Baseline Characteristics
Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
Baseline characteristics by cohort
| Measure |
All Study Participants
n=15 Participants
Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied.
If the participant entered the study on NPH, NPH insulin given twice per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on once per day Lantus. Upon the second overnight visit, Lantus insulin and blood glucose outcomes was studied
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.8 kg/m2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
C-peptide
|
0.1 nmole/L
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Diabetes duration
|
22.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Type of Insulin at First Overnight Visit
Lantus (glargine)
|
10 participants
n=5 Participants
|
|
Type of Insulin at First Overnight Visit
NPH
|
5 participants
n=5 Participants
|
|
Fast Acting Insulin
Humalog
|
8 participants
n=5 Participants
|
|
Fast Acting Insulin
Novolog
|
6 participants
n=5 Participants
|
|
Fast Acting Insulin
Regular
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: OvernightPopulation: All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.
Cumulative sum of repeatedly measured blood glucose values (mg/dl) beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on neutral protamine Hagedorn (NPH) insulin as the long acting insulin; the other overnight was glargine (Lantus) insulin as the the long acting insulin.
Outcome measures
| Measure |
Glargine (Lantus) Insulin
n=15 Participants
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
|
NPH Insulin
n=15 Participants
NPH was given at 22:00 on the evening of the overnight admission.
|
|---|---|---|
|
Blood Glucose Area Under the Curve (AUC)
|
1673.33 mg*10hr/dL
Standard Deviation 760.7
|
1395 mg*10hr/dL
Standard Deviation 384.9
|
PRIMARY outcome
Timeframe: OvernightPopulation: All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.
Average value of repeatedly measured absolute values beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on NPH insulin as the long acting insulin; the other overnight was glargine(Lantus) insulin as the the long acting insulin.
Outcome measures
| Measure |
Glargine (Lantus) Insulin
n=15 Participants
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
|
NPH Insulin
n=15 Participants
NPH was given at 22:00 on the evening of the overnight admission.
|
|---|---|---|
|
Blood Glucose
|
9.6 mmol/l
Standard Deviation 0.3
|
7.9 mmol/l
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: OvernightNPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours.
Outcome measures
| Measure |
Glargine (Lantus) Insulin
n=15 Participants
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
|
NPH Insulin
n=15 Participants
NPH was given at 22:00 on the evening of the overnight admission.
|
|---|---|---|
|
Insulin Dose
|
20.2 units
Standard Deviation 11.7
|
20.7 units
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: OvernightPopulation: Participants completing both overnight visits were included in the analysis.
Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00.
Outcome measures
| Measure |
Glargine (Lantus) Insulin
n=15 Participants
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
|
NPH Insulin
n=15 Participants
NPH was given at 22:00 on the evening of the overnight admission.
|
|---|---|---|
|
Cortisol
|
380.45 nmol/l
Standard Deviation 143.48
|
388.61 nmol/l
Standard Deviation 122.1
|
SECONDARY outcome
Timeframe: OvernightPopulation: Participants completing both overnight visits were included in the analysis.
Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00.
Outcome measures
| Measure |
Glargine (Lantus) Insulin
n=15 Participants
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
|
NPH Insulin
n=15 Participants
NPH was given at 22:00 on the evening of the overnight admission.
|
|---|---|---|
|
Glucagon
|
58.8 mcg/l
Standard Deviation 19.0
|
54.3 mcg/l
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: OvernightPopulation: Participants completing both overnight visits were included in the analysis.
Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00.
Outcome measures
| Measure |
Glargine (Lantus) Insulin
n=15 Participants
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
|
NPH Insulin
n=15 Participants
NPH was given at 22:00 on the evening of the overnight admission.
|
|---|---|---|
|
Growth Hormone
|
1.09 ug/l
Standard Deviation 1.61
|
1.27 ug/l
Standard Deviation 2.3
|
Adverse Events
NPH Insulin
Lantus Insulin
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