| Trial ID: | L3371 |
| Source ID: | NCT00694122
|
| Associated Drug: |
Lantus (Glargine)
|
| Title: |
Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
|
| Acronym: |
DAWN
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00694122/results
|
| Conditions: |
Type 1 Diabetes|Dawn Phenomenon
|
| Interventions: |
DRUG: Lantus (glargine)
|
| Outcome Measures: |
Primary: 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 | Secondary: Insulin Dose, NPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours., Overnight|Cortisol, Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00., Overnight|Glucagon, Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00., Overnight|Growth Hormone, Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00., Overnight
|
| Sponsor/Collaborators: |
Sponsor: Massachusetts General Hospital | Collaborators: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
27
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-06
|
| Completion Date: |
2010-11
|
| Results First Posted: |
2014-10-21
|
| Last Update Posted: |
2014-10-21
|
| Locations: |
Massachusettes General Hospital/ Diabetes Research Center, Boston, Massachusetts, 02114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00694122
|
