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Clinical Trial Details

Trial ID: L2896
Source ID: NCT00716092
Associated Drug: Placebo (Linagliptin)
Title: The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00716092/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo (linagliptin)|DRUG: Placebo (linagliptin)|DRUG: Sitagliptin|DRUG: Placebo (sitagliptin)|DRUG: Placebo (sitagliptin)|DRUG: Linagliptin
Outcome Measures: Primary: Weighted Mean Glucose (WMG) Change From Baseline at Day 28, The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG., Baseline and day 28|GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28, The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1., Baseline and day 28 | Secondary: Fasting Plasma Glucose (FPG) Change From Baseline at Day 28, The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG., Baseline and day 28|Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28, The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h)., Baseline and day 28 | Other: Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28, The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG., Baseline and day 28|Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28, The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1., Baseline and day 28|Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28, The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG., Baseline and day 28|Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28, The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG., Baseline and day 28
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 121
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2008-07
Completion Date:
Results First Posted: 2011-06-15
Last Update Posted: 2014-06-27
Locations: 1218.37.49003 Boehringer Ingelheim Investigational Site, Berlin, Germany|1218.37.49002 Boehringer Ingelheim Investigational Site, Mainz, Germany|1218.37.49001 Boehringer Ingelheim Investigational Site, Neuss, Germany
URL: https://clinicaltrials.gov/show/NCT00716092

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress