A Phase 4 interventional study of Entresto and Sitagliptin in Type2 Diabetes, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-05.
Sponsored by University of Copenhagen · Phase 4, Interventional, and Treatment
Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans with type 2 diabetes is unknown.
We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or placebo, to patients with type 2 diabetes during a standardized meal and measured plasma concentrations of GLP-1
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Participants are subjected to a standardized meal
Drug: Placebo
194 mg sacubitril / 206 mg valstartan (entresto) as one single dose followed by a standardized meal
Drug: Entresto
200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
Drug: Sitagliptin
194 mg sacubitril / 206 mg valstartan (entresto) + 200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
Drug: Entresto · Drug: Sitagliptin
206mg valsartan as one single dose followed by a standardized meal
Drug: Valsartan
Single dose administration of entresto
Single dose administration of sitagliptin
single doses administration of valsartan
placebo day
Blood Glucose
Plasma Concentrations of glucose
Time frame: 3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of GLP-1
Time frame: 3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of GIP
Time frame: 3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Glucagon
Time frame: 3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Insulin
Time frame: 3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of C-Peptide
Time frame: 3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Amino Acids
Time frame: 3 hours after treatment ( during the subsequent standardized meal)
Plan to share: Undecided — Undecided
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University of Copenhagen