| Trial ID: | L6090 |
| Source ID: | NCT02752113
|
| Associated Drug: |
Empagliflozin And Linagliptin
|
| Title: |
Effects of Empagliflozin + Linagliptin vs Metformin + Insulin Glargine on Renal and Vascular Changes in Type 2 Diabetes
|
| Acronym: |
ELMI
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Empagliflozin and Linagliptin|DRUG: Metformin and Insulin sc
|
| Outcome Measures: |
Primary: Effect of empagliflozin plus linagliptin vs metformin plus insulin glargine on basal NO activity of renal vasculature (response of RPF (renal plasma flow) to L-NMMA (NG-monomethyl-L-arginine) infusion), Poor glycemic control is related to hyperperfusion and increased basal nitric oxide (NO) activity secondary to increased oxidative stress that leads to impaired endothelial function in early diabetes., at baseline and after 3 months on empagliflozin plus linagliptin or metformin plus insulin glargine, respectively | Secondary: Changes in oxidative stress level of renal vasculature (response of RPF to vitamin C infusion), at baseline and after 3 months on empagliflozin plus linagliptin or metformin plus insulin glargine, respectively|changes in intraglomerular resistances (Ra and Re) and Pglom, at baseline and after three months|changes in albuminuria (urinary albumin to creatinine ratio [UACR]), assessed in the 24-hour urine, at baseline and after three months
|
| Sponsor/Collaborators: |
Sponsor: Institut für Pharmakologie und Präventive Medizin | Collaborators: University of Erlangen-Nürnberg Medical School
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
101
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-04
|
| Completion Date: |
2019-05
|
| Results First Posted: |
|
| Last Update Posted: |
2019-07-29
|
| Locations: |
Clinical Research Center, Dept of Nephrology and Hypertenison, University of Erlangen/Nürnberg, Erlangen, Bavaria, 91054, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02752113
|
