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Trial record 81 of 1007 for:    Area Under Curve AND insulin

Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon (DAWN)

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ClinicalTrials.gov Identifier: NCT00694122
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
David M. Nathan, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 1 Diabetes
Dawn Phenomenon
Intervention Drug: Lantus (glargine)
Enrollment 27
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Lantus First, Then NPH NPH First, Then Lantus
Hide Arm/Group Description 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 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.
Period Title: First Intervention (3-4 Weeks)
Started 20 [1] 7 [2]
Completed 10 5
Not Completed 10 2
Reason Not Completed
Withdrawal by Subject             7             0
Lost to Follow-up             1             1
Did not meet entrance criteria             2             1
[1]
Started Lantus then on NPH.
[2]
Started on NPH then on Lantus.
Period Title: Washout (1 Day)
Started 10 5
Completed 10 5
Not Completed 0 0
Period Title: Second Intervention (3-4 Weeks)
Started 10 5
Completed 10 5
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

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

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
46.5  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
8
  53.3%
Male
7
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 15 participants
25.8  (3.3)
[1]
Measure Description: BMI (kg/m2) was calculated from measured height and weight. Height was obtained using a wall mounted stadiometer and weight was performed using a digital scale.
C-peptide   [1] 
Mean (Standard Deviation)
Unit of measure:  nmole/L
Number Analyzed 15 participants
0.1  (0)
[1]
Measure Description: Fasting blood was drawn. C-peptide (nmole/L) was determined.
Diabetes duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
22.8  (10.2)
[1]
Measure Description: Self reported duration of type 1 diabetes.
Type of Insulin at First Overnight Visit   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
Lantus (glargine) 10
NPH 5
[1]
Measure Description: Participants entered the study on either Lantus or NPH. .
Fast Acting Insulin  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
Humalog 8
Novolog 6
Regular 1
1.Primary Outcome
Title Blood Glucose Area Under the Curve (AUC)
Hide Description 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.
Time Frame Overnight
Hide Outcome Measure Data
Hide Analysis Population Description
All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.
Arm/Group Title Glargine (Lantus) Insulin NPH Insulin
Hide Arm/Group Description:
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
NPH was given at 22:00 on the evening of the overnight admission.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mg*10hr/dL
1673.33  (760.7) 1395  (384.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine (Lantus) Insulin, NPH Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments No adjustments were made. T-test type: Paired samples t-test (df=14) was performed using 15 within subject differences.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 277.9
Confidence Interval (2-Sided) 95%
-75.9 to 631.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 164.9
Estimation Comments The comparative measures was defined as (mean AUC of glargine (Lantus)) minus (mean AUC of NPH).
2.Primary Outcome
Title Blood Glucose
Hide Description 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.
Time Frame Overnight
Hide Outcome Measure Data
Hide Analysis Population Description
All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.
Arm/Group Title Glargine (Lantus) Insulin NPH Insulin
Hide Arm/Group Description:
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission. .
NPH was given at 22:00 on the evening of the overnight admission.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mmol/l
9.6  (0.3) 7.9  (3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine (Lantus) Insulin, NPH Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Insulin Dose
Hide Description NPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours.
Time Frame Overnight
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glargine (Lantus) Insulin NPH Insulin
Hide Arm/Group Description:
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
NPH was the given at 22:00 on the evening of the overnight admission.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units
20.2  (11.7) 20.7  (10.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glargine (Lantus) Insulin, NPH Insulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Cortisol
Hide Description Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00.
Time Frame Overnight
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing both overnight visits were included in the analysis.
Arm/Group Title Glargine (Lantus) NPH Insulin
Hide Arm/Group Description:
glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
NPH was given at 22:00 on the evening of the overnight admission.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: nmol/l
380.45  (143.48) 388.61  (122.1)
5.Secondary Outcome
Title Glucagon
Hide Description Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00.
Time Frame Overnight
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing both overnight visits were included in the analysis.
Arm/Group Title Glargine (Lantus) Insulin NPH Insulin
Hide Arm/Group Description:
Glargine (Lantus) was given at 22:00 on the evening of the overnight admission.
NPH was given at 22:00 on the evening of the overnight admission.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mcg/l
58.8  (19.0) 54.3  (19.0)
6.Secondary Outcome
Title Growth Hormone
Hide Description Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00.
Time Frame Overnight
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing both overnight visits were included in the analysis.
Arm/Group Title Glargine (Lantus) Insulin NPH Insulin
Hide Arm/Group Description:
Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
NPH was given at 22:00 on the evening of the overnight admission.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: ug/l
1.09  (1.61) 1.27  (2.3)
Time Frame During active study participation while on either NPH or Lantus insulin. Approximately, 8-12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NPH Insulin Lantus Insulin
Hide Arm/Group Description Individuals on NPH insuling as long acting insulin. Individuals on Lantus insulin as long acting insulin.
All-Cause Mortality
NPH Insulin Lantus Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NPH Insulin Lantus Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NPH Insulin Lantus Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Limitation: delayed and slow participant recruitment due to expansive use of insulin pumps and participants unwilling to cross over to alternate insulin.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David M. Nathan, MD
Organization: Massachusetts General Hospital
Phone: 617-726-1848
Responsible Party: David M. Nathan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00694122     History of Changes
Other Study ID Numbers: 2005-P-002515/24
First Submitted: June 6, 2008
First Posted: June 10, 2008
Results First Submitted: November 4, 2013
Results First Posted: October 21, 2014
Last Update Posted: October 21, 2014