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

NCT01169818 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2013-07-08

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • China
  • India
  • Japan
  • Pakistan
  • Philippines
  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01169818 on ClinicalTrials.gov