A Randomised, Multicentre, Open-Label, Parallel-Group, 24-Week Phase IV Study Comparing the Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care: General Practitioner Initiation of Insulin Glargine Versus the Usual Standard of Care
Overview
- Phase
- Phase 4
- Intervention
- Oral Anti Diabetics (OAD)
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Sanofi
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Usual standard of care
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)
Intervention: Oral Anti Diabetics (OAD)
General Practitioner initiation with insulin glargine
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.
Intervention: INSULIN GLARGINE (HOE901)
Outcomes
Primary Outcomes
The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
Time Frame: From week 0 to week 24
Secondary Outcomes
- 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)