General practitioner Implementation in Asia of Normoglycaemic Targets
- Conditions
- Type 2 diabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12607000305426
- Lead Sponsor
- Baker IDI Heart and Diabetes Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 386
• Clinical diagnosis of type 2 diabetes (defined according to IDF Guidelines) for a minimum of 6 months prior to Study Visit 1 • Patients for whom the GP is the primary medical provider of diabetes care and for whom referral to another doctor for diabetes care is not anticipated within 3 months of Study Visit 1• Patients who give informed consent to participate.
• Patients with type 1 diabetes mellitus• Patients with any previous episode of ketoacidosis• Patients who required chronic use (= 6 months) of insulin at any time in the past, with the exception of females during pregnancy• Patients receiving insulin treatment at Study Visit 1 or within the previous 6 months, with the exception of patients who received short-term treatment (= 7 days) with insulin to maintain glycaemic control for an acute event (e.g. hospitalisation or medical procedure/intervention, infection or trauma).• Treatment with glucocorticoid at Study Visit 1 or within the previous 6 months, with the exception of topical or inhaled glucocorticoid• Females who are pregnant or considering pregnancy or stopping contraception within the course of the study• Patients with end-stage renal disease, defined as glomerular filtration rate (GFR) by the MDRD (Modification of Diet in Renal Disease) formula < 15 ml/min/1.73 m2, or on renal replacement therapy with haemodialysis, peritoneal dialysis or renal transplant. The MDRD formula is: GFR = 186 x [serum creatinine]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.212 if subject is black] if serum creatinine is measured in mg/dL.GFR = 186 x [serum creatinine/88.4]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.212 if subject is black] if serum creatinine is measured in umol/L. • Patients with psychiatric disease, active drug or alcohol abuse or other cognitive impairment that may interfere with treatment compliance.• Receipt of any investigational drug within 30 days of Study Visit 1.• Patients receiving diabetes care from another doctor (specialist endocrinologist, general physician, or another GP) Other eligibility criteria considerationsThe HbA1c at entry for newly recruited patients will be monitored centrally. If there is a significant risk that more than 25% of the total study population will have a baseline HbA1c = 6.5%, then recruitment of subsequent patients will be restricted to those with HbA1c > 6.5%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in mean glycoslyated haemoglobin (HbA1c) at month 6 among subjects with a baseline HbA1c = 6.5%[At baseline and month 6]
- Secondary Outcome Measures
Name Time Method