Effect of Neprilysin on Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes

Phase 4

Completed

• Conditions: Type2 Diabetes
• Interventions: Drug: Placebo; Drug: Entresto; Drug: Sitagliptin; Drug: Valsartan

• Registration Number: NCT03893526
• Lead Sponsor: University of Copenhagen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-25
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Type 2 Diabetes
• Oral Antidiabetics Medicine Only
• Body Mass Index of 25-35
• Type 2 Diabetes

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Exclusion Criteria

• acute diseases within the two weeks
• chronic diseases
• smoker
• alcoholism, drug addiction or recent weight loss
• blood donation within the last 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants are subjected to a standardized meal
Entrestro	Entresto	194 mg sacubitril / 206 mg valstartan (entresto) as one single dose followed by a standardized meal
Sitagliptin	Sitagliptin	200mg sitagliptin (100mg the night before and 100mg on the study day) as one single dose followed by a standardized meal
Entrestro + sitagliptin	Entresto	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
Entrestro + sitagliptin	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
Valsartan	Valsartan	206mg valsartan as one single dose followed by a standardized meal

Primary Outcome Measures

Name	Time	Method
Blood Glucose	3 hours after treatment ( during the subsequent standardized meal)	Plasma Concentrations of glucose

Secondary Outcome Measures

Name	Time	Method
Plasma Concentrations of Glucagon	3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Insulin	3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of GLP-1	3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of GIP	3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of C-Peptide	3 hours after treatment ( during the subsequent standardized meal)
Plasma Concentrations of Amino Acids	3 hours after treatment ( during the subsequent standardized meal)

Trial Locations

Locations (1)

Hvidovre Hospital; 🇩🇰 Hvidovre, RegionH, Denmark