Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4121
Source ID: NCT02669524
Associated Drug: Ly2409021
Title: Dissection of the Gastrointestinal-mediated Glucose Disposal and Incretin Defect in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: LY2409021|DRUG: LY2409021 placebo|PROCEDURE: OGTT|PROCEDURE: IIGI|PROCEDURE: Standardised liquid meal
Outcome Measures: Primary: Differences in GIGD (%), GIGD = Gastrointestinal glucose disposal. GIGD (%) = 100% × (glucoseOGTT-glucoseIIGI)/glucoseOGTT., Comparison between experimental days with and without the glucagon receptor antagonist . The glucose disposal at time 240 minutes will be used.|Difference in postprandial glucose excursions, 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 and without the glucagon receptor antagonist. | Secondary: Incretin effect, The incretin effect (100% × \[β-cell secretory response to oral glucose tolerance test - intravenous β-cell secretory response\]/β-cell secretory response to oral glucose tolerance test), Insulin AUC time frame: 0,10, 20, 30, 50, 60, 70, 90, 105, 120, 150, 240 minutes. Comparison between experimental days with and without the glucagon receptor antagonist|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., Insulin, C-peptide, glucagon, GIP and GLP-1 serum/plasma concentrations will be measured in pM., Time frame: 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 clamp experiment food intake will be examined with an ad libitum meal. The weight of the food will be measured i grams and calculated to the energy intake in kcal/kJ., At time 240 to 270, the participants will eat an ad libitum meal. Comparison between experimental days with and without the glucagon receptor antagonist|Changes in blood pressure (mmHg), Measured at time 0 and time 210 minutes. Comparison between experimental days with and without the glucagon receptor antagonist|Changes in pulse rate (beat per minute), Measured at time 0 and at time 210 minutes. Comparison between experimental days with and without the glucagon receptor antagonist|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|Fibroblast growth factor-21, plasma values of FGF-21, -30,-15, 0, 10, 20, 30, 50, 70, 90, 105, 120, 150, 240 minutes
Sponsor/Collaborators: Sponsor: University Hospital, Gentofte, Copenhagen | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2015-10
Completion Date: 2016-08
Results First Posted:
Last Update Posted: 2016-10-25
Locations: Center for Diabetes Research, Gentofte Hospital, Copenhagen University, Hellerup, DK-2900, Denmark
URL: https://clinicaltrials.gov/show/NCT02669524