| Trial ID: | L3864 |
| Source ID: | NCT00686712
|
| Associated Drug: |
1- Insulin Glargine Qhs
|
| Title: |
Insulin Glargine at Bedtime or in AM Versus NPH
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00686712/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: 1- Insulin glargine QHS|DRUG: 2 - Insulin glargine QAM|DRUG: 3 - NPH insulin QHS
|
| Outcome Measures: |
Primary: Hemoglobin A1c Change From Baseline, Baseline to 6 months | Secondary: Frequency of Glucose Readings < 130 mg/dL, Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL, 6 months|Frequency of Total Hypoglycemic Reactions, Frequency of hypoglycemic reactions without regard to time of occurrence, 6 months|Frequency of Severe Hypoglycemic Reactions, Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person, 6 months|Body Mass Index Change From Baseline, Change in body mass index from baseline BMI measurement, 6 months|Total Daily Insulin Dose, Total daily number of units of insulin used, 6 months|Any Adverse Event Other Than Hypoglycemia, Any reported adverse event that is not hypoglycemia, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Charles Drew University of Medicine and Science | Collaborators: National Center for Research Resources (NCRR)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
108
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-02
|
| Completion Date: |
2009-08
|
| Results First Posted: |
2010-10-07
|
| Last Update Posted: |
2017-05-22
|
| Locations: |
Charles Drew University of Medicine and Science, Los Angeles, California, 90059, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00686712
|
