At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 121 enrolled
Drug / intervention
Placebo (linagliptin) +5 moredrug
Likely dose
Sitagliptin 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 4-week, Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group Study Comparing the Influence of BI 1356 (5 mg) and Sitagliptin (100 mg) Administered Orally Once Daily on Various Biomarkers in Type 2 Diabetic Patients
In Brief
A Phase 2 clinical trial evaluating Placebo (linagliptin), Sitagliptin, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 121 participants across 3 sites.
Detailed Summary
The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionNov 2008
TodayJul 2026
First PostedJul 16, 2008
Enrollment StartJul 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.0 years ago
Interventions
Placebo (linagliptin)drug
once daily for 28 days
Placebo (linagliptin)drug
once daily for 28 days
Sitagliptindrug
100 mg once daily for 28 days
Placebo (sitagliptin)drug
once daily for 28 days
Placebo (sitagliptin)drug
once daily for 28 days
Linagliptindrug
5mg once daily for 28 days