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Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care

NCT00950534 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2011-11-10

No results posted yet for this study

Summary

The primary objective is to demonstrate the improvement in glycosylated haemoglobin (HbA1c) levels after general practitioner (GP) initiation and management of type 2 diabetes mellitus (T2DM) with insulin glargine compared with their usual clinical practice.

The secondary objective is to demonstrate the importance of GP initiation of insulin glargine for the treatment of T2DM.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

INSULIN GLARGINE (HOE901)

The dose of insulin glargine will be titrated toward a fasting plasma glucose (FPG) target of 5.5 mmol/L. Treatment with oral antidiabetic drugs (OADs) prescribed before study entry may continue (except Sitagliptin, Acarbose, Rosiglitazone)

DRUG

Oral Anti Diabetics (OAD)

Patients treated with the usual standard of care (OAD dose titration, addition of a second or third OAD or referral to an endocrinologist) until optimal doses are reached to maintain a FPG of 5.5 mmol/L

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Australia

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 NCT00950534 on ClinicalTrials.gov