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Clinical Trial Details

Trial ID: L5748
Source ID: NCT02792400
Associated Drug: Ly2403021
Title: The Role of Glucagon in the Effects of Dipeptidyl Peptidase-4 Inhibitors and Sodium-glucose Co-transporter-2 Inhibitors
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: LY2403021|DRUG: LY2403021 placebo|PROCEDURE: Standardised liquid meal|DRUG: Linagliptin|DRUG: Linagliptin placebo|DRUG: Empagliflozin|DRUG: Empagliflozin placebo
Outcome Measures: Primary: Difference in postprandial glucose excursions (linagliptin), Difference in postprandial glucose excursions (measured as incremental (baseline substracted) area under the curve (AUC) values)., Area under the curve (AUC) time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 105, 120, 150, 180, 210, 240 minutes. Comparison between experimental days with linagliptin (A1, A2, A3, A4)|Difference in postprandial glucose excursions, Difference in postprandial glucose excursions (measured as incremental (baseline substracted) area under the curve, Area under the curve (AUC) time frame: 0, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 105, 120, 150, 180, 210, 240 minutes. Comparison between experimental days with empagliflozin (B1, B2, B3, B4) | Secondary: Endogenous glucose production, Glucose rate of appearance will be calculated by the non-steady state equation using double tracer technique., Plasma concentration of 6,6^2 H2-glucose and U-13C^6-glucose at times: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes.|Lipolysis, Glycerol disappearance will be calculated by the non-steady state equation using double tracer technique., Plasma concentration of 1,1,2,3,3-^2-H5 - glycerol measured at times: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes.|Serum/plasma concentrations of insulin, C-peptide, glucagon, GIP and GLP-1., : 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes|Appetite, Appetite will be evaluated with a visual analogue scale (VAS)., VAS scales will be handed out at time 0, 30, 60, 90, 120, 150, 180 and 240 minutes.|Energy intake (kcal/kJ), At the end of the standardised liquid meal test, food intake will be examined with an ad libitum meal. The weight of the food will be measured in grams and calculated to the energy intake in kcal/kJ, At time 240 to 270, the participants will eat an ad libitum meal.|Changes in blood pressure (mmHg), Measured at time 0 and time 210 minutes.|Changes in pulse rate (beat per minute), Measured at time 0 and at time 210 minutes.|Differences in gastric emptying, Measurement of p-paracetamol. Measurement of time to peak and incremental area under the curve (iAUC), -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes|Free fatty acids, Serum values of free fatty acids, -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes|Plasma Fibroblast growth factor-21, -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes|Resting energy expenditure, Resting energy expenditure evaluated by 10 minutes of indirect calorimetry., -60 to -50 and 35 to 45
Sponsor/Collaborators: Sponsor: University Hospital, Gentofte, Copenhagen | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2016-05
Completion Date: 2018-07
Results First Posted:
Last Update Posted: 2020-04-08
Locations: Center for Diabetes Research, Gentofte Hospital, Copenhagen University, Hellerup, DK-2900, Denmark
URL: https://clinicaltrials.gov/show/NCT02792400