CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 555 enrolled
Drug / intervention
Insulin Glarginedrug
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.

Search/NCT01169818
NCT01169818Phase 4Completed

Asian Treat to Target Lantus Study: A Randomized, Multicentre, Multinational, Open-Label, Parallel-Group, 24-Week Phase IV Study Evaluating the Effectiveness and Safety of Physician Versus Patient-led Initiation and Titration of Insulin Glargine in Type 2 Diabetes Mellitus

Sanofi·interventional·Posted Jul 26, 2010·Updated Jul 8, 2013

In Brief

A Phase 4 clinical trial evaluating Insulin Glargine for Diabetes Mellitus, Type 2. Completed, enrolled 555 participants across 6 sites in 6 countries.

Detailed Summary

Primary Objective: To compare patient-led titration (intervention group) versus physician-led titration (usual standard of care) in optimizing the clinical use of insulin glargine in an Asian population of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Secondary Objectives: To determine the difference in glycemic control, safety, quality of life and treatment satisfaction between patient-led titration and usual care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, India, Japan, Pakistan, Philippines, Russia
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2010
Enrollment StartAug 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.9 years ago

Interventions

Insulin Glarginedrug

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: initial: once a day in the evening at bedtime. Titration will occur each time the middle FPG (Fasting Plasma Glucose) value is above target