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Clinical Trial Details

Trial ID: L7001
Source ID: NCT01937598
Associated Drug: Placebo
Title: Antidiabetic Effects of Adding a DPP-4 Inhibitor to Pre-Existing Treatment With an Incretin Mimetic in Patients With T2D
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01937598/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Placebo|OTHER: Mixed meal test|DRUG: Liraglutide|DRUG: Sitagliptin
Outcome Measures: Primary: Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC), Incremental area under the plasma glucose (BG) concentration-time profile (AUC) immediately before to 300 min after a mixed meal test. In addition, the time course of BG values will be analysed with an ANCOVA model for repeated measurements with placebo baseline values as covariate. Time points to create the curce were 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 and 300 minutes post mixed meal test., 0 to 300 min post mixed meal test | Secondary: AUC Plasma Glucose, Incremental AUC from 0 to 300 min, Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|AUC Insulin, Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|AUC C-peptide, Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|AUC Glucagon, Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|AUC Total GLP-1, Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|AUC Total GIP, Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|AUC Active GLP-1, Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|AUC Active GIP, Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)
Sponsor/Collaborators: Sponsor: Michael A. Nauck
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2013-08
Completion Date: 2015-06
Results First Posted: 2017-01-30
Last Update Posted: 2017-01-30
Locations: Diabeteszentrum Bad Lauterberg, Bad Lauterberg, 37431, Germany
URL: https://clinicaltrials.gov/show/NCT01937598