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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
David M. Nathan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00694122
First received: June 6, 2008
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: November 4, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Type 1 Diabetes
Dawn Phenomenon
Intervention: Drug: Lantus (glargine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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.

Participant Flow for 3 periods

Period 1:   First Intervention (3-4 Weeks)
    Lantus First, Then NPH     NPH First, Then Lantus  
STARTED     20 [1]   7 [2]
COMPLETED     10     5  
NOT COMPLETED     10     2  
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 2:   Washout (1 Day)
    Lantus First, Then NPH     NPH First, Then Lantus  
STARTED     10     5  
COMPLETED     10     5  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (3-4 Weeks)
    Lantus First, Then NPH     NPH First, Then Lantus  
STARTED     10     5  
COMPLETED     10     5  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study 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


Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.5  ± 12.5  
Gender  
[units: participants]
 
Female     8  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     15  
Study-Specific Measure [1]
[units: kg/m2]
Mean ± Standard Deviation
  25.8  ± 3.3  
Study-Specific Measure [2]
[units: nmole/L]
Mean ± Standard Deviation
  0.1  ± 0  
Study-Specific Measure [3]
[units: years]
Mean ± Standard Deviation
  22.8  ± 10.2  
Study-Specific Measure [4]
[units: participants]
 
Lantus (glargine)     10  
NPH     5  
Study-Specific Measure  
[units: participants]
 
Humalog     8  
Novolog     6  
Regular     1  
[1] 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.
[2] Fasting blood was drawn. C-peptide (nmole/L) was determined.
[3] Self reported duration of type 1 diabetes.
[4] Participants entered the study on either Lantus or NPH. .



  Outcome Measures
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1.  Primary:   Blood Glucose Area Under the Curve (AUC)   [ Time Frame: Overnight ]

2.  Primary:   Blood Glucose   [ Time Frame: Overnight ]

3.  Secondary:   Insulin Dose   [ Time Frame: Overnight ]

4.  Secondary:   Cortisol   [ Time Frame: Overnight ]

5.  Secondary:   Glucagon   [ Time Frame: Overnight ]

6.  Secondary:   Growth Hormone   [ Time Frame: Overnight ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitation: delayed and slow participant recruitment due to expansive use of insulin pumps and participants unwilling to cross over to alternate insulin.


  More Information
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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
e-mail: dnathan@partners.org


No publications provided


Responsible Party: David M. Nathan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00694122     History of Changes
Other Study ID Numbers: 2005-P-002515/24
Study First Received: June 6, 2008
Results First Received: November 4, 2013
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board