NCT00694122|CompletedPhase 3ResultsDMC
Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
DAWN
Comparison of Lantus and NPH Insulin in the Dawn Phenomenon
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Sponsor study identifier
interventional
27
1 country
1
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
June 6, 2008
Actual (reported)June 10, 2008
Actual (reported)November 2010
Actual (reported)November 2010
Actual (reported)October 21, 2014
Actual (reported)Blood Glucose Area Under the Curve (AUC)
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.
Overnight
Blood Glucose
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.
Overnight
Insulin Dose
Overnight
Cortisol
Overnight
Glucagon
Overnight
Growth Hormone
Overnight
Long acting insulin, glargine, that subject currently used as an outpatient. SC injections. Dose given at 22:00 is based on past week blood glucose data during evening overnight hours and AM glucose. 20.2 +/- 11.7 units glargine (mean +/- SD). Glargine (Lantus): Sanolfi Aventis Hourly blood glucose from 22:00 to 08:00 while receiving glargine (Lantus) insulin will be compared with the NPH insulin arm.
Long acting insulin, NPH, that participant was currently while an outpatient. SC injections. Dose (units) given at 22:00 is based on past week blood glucose during evening overnight period and AM glucose. 20.7 +/- 10.0 units NPH (mean +/- SD). NPH: Eli Lilly Hourly blood glucose from 22:00 to 08:00 while receiving glargine (Lantus) insulin will be compared with the glargine (Lantus) insulin arm.
Described in Arm Description
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusettes General Hospital/ Diabetes Research Center
Boston, Massachusetts, 02114, United States
Limitation: delayed and slow participant recruitment due to expansive use of insulin pumps and participants unwilling to cross over to alternate insulin.
David M Nathan, MD
Massachusetts General Hospital
27 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2008
First Posted
June 10, 2008
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
Contact the study team to confirm eligibility.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Last Updated
October 21, 2014
Results First Posted
October 21, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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