GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets

NCT00499824 | Completed

• 1 other identifier: IDI Project 4/2006
• Study Type: interventional
• Target: 386
• Locations: 9 countries
• Sites: 10

Brief Summary

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).

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Management guidelines; Efficacy

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline in subjects with baseline HbA1c >/=6.5%

  6 months

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Medical Practitioners who receive education on diabetes management following the guidelines of the International Diabetes Federation Western Pacific Region

Behavioral: Education of general practitioners on the IDF-WPR guidelines

2

NO INTERVENTION

Medical practitioners who follow standard practice for management of their patients with type 2 diabetes

Interventions

Education of general practitioners on the IDF-WPR guidelines BEHAVIORAL

The intervention will comprise an educational program on the guidelines for GPs, and will be carried out by the national coordinating centre in each country, based on a template provided by the international coordinating centre (International Diabetes Institute, Australia). This will involve: an initial educational symposium and a follow-up continuing medical education symposium at 3 months; paper or electronic reminders of the guidelines sent to GPs every 3 months; desktop reminder cards with guideline algorithms; insertion of a flowsheet (diabetes action plan) into the patient's medical notes by the study nurse; provision of each patient with a "diabetes passport" to be held by the patient.

1

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• International Diabetes Institute, Australia: lead
• GlaxoSmithKline: collaborator

Study Sites (10)

Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, Hong Kong, China

Location

Department of Endocrinology & Metabolism, Peking University People's Hospital

Beijing, 100044, China

Location

Diabetes and Nutrition Center, Dr. Soetomo Teaching Hospital - Airlangga University,

Surabaya, 60286, Indonesia

Location

School of Medicine and Health Sciences, Monash University House

Johor Bahru, 80100, Malaysia

Location

Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of the Philippines College of Medicine

Manila, Philippines

Location

Diabetes, Lipid and Endocrine Practice, Gleneagles Medical Centre

Singapore, 258499, Singapore

Location

Department of Endocrinology & Metabolism, Kangnam St. Mary's Hospital, The Catholic University of Medicine

Seoul, South Korea

Location

Dept of Medical Research and Education, Taipei Veterans General Hospital,

Taipei, Taiwan

Location

Diabetes and Endocrinology Unit, Department of Medicine, Rajavithi Hospital,

Bangkok, 10400, Thailand

Location

National Hospital of Endocrinology,

Hanoi, Dongda District, Vietnam

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jonathan E Shaw, MD MRCP FRACP

  International Diabetes Institute, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 4, 2010

Record last verified: 2010-05

Locations

VN (1); ID (1); MY (1); KR (1); PH (1); CN (2); TW (1); SG (1); TH (1)