Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care
Phase 4
Terminated
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: INSULIN GLARGINE (HOE901)Drug: Oral Anti Diabetics (OAD)
- Registration Number
- NCT00950534
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General Practitioner initiation with insulin glargine INSULIN GLARGINE (HOE901) Patients will be prescribed insulin glargine by their Investigator and they will be taught how to administer insulin glargine according to Australian guidelines. Patients will be treated for 24 weeks. Usual standard of care Oral Anti Diabetics (OAD) Patients will be treated by their Investigator with the usual standard of care for 24 weeks (e.g., OAD dose titration, addition of a second or third OAD, or referral to an endocrinologist)
- Primary Outcome Measures
Name Time Method The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0% From week 0 to week 24
- Secondary Outcome Measures
Name Time Method Time required to reach the target HbA1c level of < or = 7% From week 0 to week 24 The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0% From week 0 to week 24 Decrease in mean HbA1c level At week 24 Decrease in mean Fasting Plasma Glucose (FPG) At week 24 Mean change in body weight At week 24
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇦🇺Macquarie Park, Australia