| Trial ID: | L7278 |
| Source ID: | NCT03660553
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Simplified Insulin Regimen for the Elderly
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03660553/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin Glargine|DRUG: Insulin Glargine|DRUG: Insulin Aspart|DRUG: Insulin Lispro
|
| Outcome Measures: |
Primary: Hemoglobin A1c (HbA1c), The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group, 6 months | Secondary: Incidence of Any Hypoglycemia, Defined as any reported blood glucose (BG) \<70 mg/dl will be compared between the two groups, 6 months|Incidence of Severe Hypoglycemia, Any BG \<54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups., 6 months
|
| Sponsor/Collaborators: |
Sponsor: University of Miami
|
| Gender: |
ALL
|
| Age: |
OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-10-10
|
| Completion Date: |
2022-06-30
|
| Results First Posted: |
2023-12-12
|
| Last Update Posted: |
2023-12-12
|
| Locations: |
University of Miami, South Miami, Florida, 33143, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03660553
|
