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Clinical Trial Details

Trial ID: L4324
Source ID: NCT01449019
Associated Drug: Exendin(9-39)Amide
Title: The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM)
Acronym: DFG_5
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: exendin(9-39)amide|DRUG: saline|OTHER: duodenal meal|OTHER: duodenal saline
Outcome Measures: Primary: The incretin effect, The incretin effect is the difference between postprandial plasma concentrations of insulin and C-peptide, respectively, and those during the isoglycemic fasting control experiment. The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion., Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion | Secondary: Plasma concentrations of glucagon, The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion., Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion|Plasma concentrations of insulin, The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion., Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion|Plasma concentrations of C-peptide, The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion., Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion|Plasma concentrations of Glucagon-like peptide-1(7-36) (GLP-1(7-36)), The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion., Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion|Plasma concentrations of Glucose-dependent insulinotropic polpypeptide (GIP), The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion., Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
Sponsor/Collaborators: Sponsor: Ludwig-Maximilians - University of Munich
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2006-12
Completion Date: 2010-07
Results First Posted:
Last Update Posted: 2011-10-07
Locations: Ludwig Maximilians-University, Clinical Research Unit, Munich, 80999, Germany|Clinical Research unit, Dept. of Internal Medicine II - Großhadern, University of Munich, Munich, 81377, Germany
URL: https://clinicaltrials.gov/show/NCT01449019