drugset / Trial / NCT01169818

Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus

NCT01169818 ↗

Phase 4 Completed 555 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2012-06
Completion
2012-06

Outcome

Met primary endpoint

paper Patient-led titration resulted in a significantly higher drop in HbA1c value at 24 weeks when compared with physician-led titration PMID 25297660 ↗

paper (-1.40% vs. -1.25%; mean difference, -0.15; 95% confidence interval, -0.29 to 0.00; P = .043). PMID 25297660 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic — Subcutaneous