At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 316 enrolled
Drug / intervention
metformin +3 moredrug
Likely dose
metformin 1000 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 24-week, Randomized, Double-blind, Active-controlled, Parallel Group Trial to Assess the Superiority of Oral Linagliptin and Metformin Compared to Linagliptin Monotherapy in Newly Diagnosed, Treatment-naïve, Uncontrolled Type 2 Diabetes Mellitus Patients
In Brief
A Phase 4 clinical trial evaluating metformin, linagliptin, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 316 participants across 82 sites in 12 countries.
Detailed Summary
The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCanada, India, Israel, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Sri Lanka, Thailand, Ukraine, United States
CollaboratorsEli Lilly and Company
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionApr 2013
TodayJul 2026
First PostedJan 20, 2012
Enrollment StartJan 1, 2012
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.5 years ago
Interventions
metformindrug
1000 mg to 2000 mg per day
linagliptindrug
5 mg daily
metformin placebodrug
0 to 2 tablets daily
metformin placebodrug
4 tablets daily