At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 106 enrolled
Drug / intervention
Insulin Glargine +3 moredrug
Likely dose
Not stated in 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.
Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study.
In Brief
A Phase 4 clinical trial evaluating Insulin Glargine, Glimepiride, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 106 participants across 3 sites in 3 countries.
Detailed Summary
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesRussia, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionAug 2008
TodayJul 2026
First PostedAug 7, 2006
Enrollment StartJul 1, 2006
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.9 years ago
Interventions
Insulin Glarginedrug
One daily injection at bedtime
Glimepiridedrug
At same dosage as during the run-in period
Insulin Glulisinedrug
One bolus given before the main meal
Metformindrug
At same dosage as during the run-in period