Type 2 Diabetes Mellitus Clinical Trial
— GIANTOfficial title:
GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets
To test whether the International Diabetes Federation - Western Pacific Region (IDF-WPR) Guidelines are more effective than standard practices in primary care (general practitioner) clinics for the management of type 2 diabetes mellitus (T2DM) in Asia. A 12-month multinational multicentre prospective cluster randomisation clinical trial within a primary care setting, with 2 parallel treatment arms: diabetes management using IDF-WPR guidelines versus standard clinic practices. 400 subjects will be recruited from 100 sites (4 subjects per site) in ten Asian countries (China, Hong Kong, Indonesia, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand and Vietnam).
Status | Completed |
Enrollment | 386 |
Est. completion date | February 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 75 Years |
Eligibility |
INCLUSION CRITERIA - Men or women who are 30 to 75 years of age (inclusive) at Study Visit 1. - 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. EXCLUSION CRITERIA - 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. - 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 considerations The 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%. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
China | Department of Endocrinology & Metabolism, Peking University People's Hospital | Beijing | |
China | Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong | Shatin | Hong Kong |
Indonesia | Diabetes and Nutrition Center, Dr. Soetomo Teaching Hospital - Airlangga University, | Surabaya | |
Korea, Republic of | Department of Endocrinology & Metabolism, Kangnam St. Mary's Hospital, The Catholic University of Medicine | Seoul | |
Malaysia | School of Medicine and Health Sciences, Monash University House | Johor Bahru | |
Philippines | Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of the Philippines College of Medicine | Manila | |
Singapore | Diabetes, Lipid and Endocrine Practice, Gleneagles Medical Centre | Singapore | |
Taiwan | Dept of Medical Research and Education, Taipei Veterans General Hospital, | Taipei | |
Thailand | Diabetes and Endocrinology Unit, Department of Medicine, Rajavithi Hospital, | Bangkok | |
Vietnam | National Hospital of Endocrinology, | Hanoi | Dongda district |
Lead Sponsor | Collaborator |
---|---|
International Diabetes Institute, Australia | GlaxoSmithKline |
China, Indonesia, Korea, Republic of, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c from baseline in subjects with baseline HbA1c >/=6.5% | 6 months | No | |
Secondary | HbA1c, FPG, BP, lipids; hypoglycemic events; health care use; number of GP HbA1c measurements; number of treatment escalations; adverse events; barriers to guideline implementation; determine if study patients are representative of GP's diabetic practice | 6 & 12 months | No |
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