Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3719
Source ID: NCT02212067
Associated Drug: Semaglutide
Title: A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: placebo
Outcome Measures: Primary: Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes, Day -1, day 86|Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT)., Day -1, day 86 | Secondary: Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge, Day -1, day 86|Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge, Day -1, day 86|24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals, Day -1, day 85|Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. arginine application; ISR will be derived from the C-peptide concentration profile, Day -1, day 86|Area under the ISR curve over the 5-12 mmol/L (90-216 mg/dL) glucose interval; ISR will be derived from the C-peptide concentration profile, Day -1, day 87|Slope of the ISR vs. glucose curve (dose-response relationship), Day -1, day 87
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 87
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-08-11
Completion Date: 2015-05-11
Results First Posted:
Last Update Posted: 2018-03-07
Locations: Novo Nordisk Investigational Site, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT02212067