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Trial registered on ANZCTR


Registration number
ACTRN12607000305426
Ethics application status
Approved
Date submitted
18/12/2006
Date registered
8/06/2007
Date last updated
18/12/2018
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
18/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
General practitioner Implementation in Asia of Normoglycaemic Targets
Scientific title
Is education about Type 2 Diabetes Mellitus (T2DM) management using the IDF-WPR publication “Type 2 Diabetes Practical Targets and Treatments, Fourth Edition” more effective than standard practice in primary care (general practice) for the management of T2DM?
Secondary ID [1] 296898 0
GIANT
Universal Trial Number (UTN)
Trial acronym
GIANT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 1848 0
Condition category
Condition code
Metabolic and Endocrine 1942 1942 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective multinational, multicentre, cluster-randomised study conducted within the primary care setting, with two parallel treatment arms: standard clinical practice versus education on diabetes management using International Diabetes Federation - Western Pacific Region (IDF-WPR) “Type 2 diabetes practical targets and treatments”. The study duration will be 12 months.

General Practitioners (GPs) will be randomised to receive education on the IDF-WPR guidelines or to receive no trial-related education.
• GPs in both groups will be required to recruit a defined number of their own patients meeting the eligibility criteria. The complete entry criteria are detailed in a following section.
• GPs in both groups will manage the recruited patients according to their own clinical judgement. Frequency of patient visits to the GP’s clinic will be determined by the GP. All medication prescribed by the GPs should already be registered in the participating countries.
• Blood sampling of patients will be required at Study Visit 1 (Screening/Baseline), Study Visit 2 (month 6) and Study Visit 3 (month 12).

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). Comprehensive evidence-based reviews of studies on physician performance improvement and effective organisational interventions that improve diabetes care have been published (Bero, Grilli et al. 1998; Smith 2000; Renders, Valk et al. 2001; Fleming, Silver et al. 2004; Bloom 2005). Based on these studies, the educational program for the GPs randomised to the intervention arm will:

1. Combine didactic and interactive sessions.
2. Involve opinion leaders, i.e. the national lead investigator
3. Aim to resolve barriers to practical implementation of guidelines already identified from previous studies (e.g. discuss starting insulin)
4. Present the evidence for the guidelines.
5. Highlight any conflicts between the guidelines and local prescribing regulations, and confirm the need to follow the local prescribing regulations in these instances
6. Involve an initial educational symposium and a follow-up continuing medical education symposium at 3 months


Organisational changes to improve guideline adherence for the study will include:
1. Paper or electronic reminders of the guidelines will be sent to GPs every 3 months.
2. Desktop reminders cards with key guideline algorithms.
3. Insertion of a flowsheet (diabetes action plan) into the patient’s medical notes by the study nurse (at the time of review of the practitioner’s baseline HbA1c utilisation).

Patient–centred approaches to improve guideline adherence for the study will include:
1. Encouragement and empowerment of patients to ask questions of the treating practitioners
2. Provision of each patient with a “diabetes passport” to be held by the patient, to encourage discussion between the patient and practitioner and also recording of results of medical examinations. This will be provided at the baseline visit to the national coordinating centre.
Intervention code [1] 1512 0
Treatment: Other
Comparator / control treatment
Comparator is management of diabetes by general practitioners who follow International Diabetes Federation-Western Pacific Region (IDF-WPR) guidelines. The control is management of diabetes by general practitioners who follow standard care.
Control group
Active

Outcomes
Primary outcome [1] 2759 0
Change from baseline in mean glycoslyated haemoglobin (HbA1c) at month 6 among subjects with a baseline HbA1c = 6.5%
Timepoint [1] 2759 0
At baseline and month 6
Secondary outcome [1] 4648 0
1. Glycaemic control
Timepoint [1] 4648 0
a) Change from baseline in mean HbA1c and Fasting Plasma Glucose (FPG) at month 6 in the whole study population.
b) Change from baseline in mean HbA1c and FPG at month 12 in those with baseline HbA1c =6.5%, and in the whole study population.
c) Change from baseline in mean HbA1c and FPG at month 6 and month 12 in those with baseline HbA1c < 9.0%.
d) Change from baseline in mean HbA1c and FPG at month 6 and month 12 in those with baseline HbA1c = 9.0%.
e) Percentage of patients with HbA1c <6.5% at month 6 and month 12
f) Mean number of hypoglycaemic episodes per month, at month 6 and month 12
Secondary outcome [2] 4649 0
2. Blood Pressure (BP)
Timepoint [2] 4649 0
a) Changes from baseline in systolic BP and diastolic BP at month 6 and month 12
b) Percentage of patients with BP = target at month 6 and month 12 (per IDF Guidelines)
Secondary outcome [3] 4650 0
3. Lipids
Timepoint [3] 4650 0
a) Changes from baseline in lipid levels (total cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL] and triglycerides) at month 6 and month 12
b) Percentage of patients achieving target levels for each lipid parameter (total cholesterol, HDL, LDL and triglycerides) at month 6 and month 12 (per IDF Guidelines)
Secondary outcome [4] 4651 0
4. Health Outcomes
Timepoint [4] 4651 0
Health care utilisation at month 6 and month 12
Secondary outcome [5] 4652 0
5. Other Measures
Timepoint [5] 4652 0
a) Number of times HbA1c was measured by the GP in the preceding 6 month period for each subject at month 0, 6 and 12
b) Number of treatment escalations for each subject (including dose up-titration and addition of new medication)
c) Number of hypoglycaemic episodes for each subject in the preceding 3 month period at month 0, 6 and 12
d) Adverse events (serious and non-serious adverse events)
e) Collection of data on patients with diabetes not recruited to this study but seen by the GP during the recruitment phase, in order to determine how representative the study population is.
f) Identification of barriers to implementation of diabetes clinical practice guidelines through a GP questionnaire administered after the last patient last visit of the study.

Eligibility
Key inclusion criteria
• 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.
Minimum age
30 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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. 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a random permutation program in S-plus to generate Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 447 0
Hong Kong
State/province [1] 447 0
Country [2] 448 0
China
State/province [2] 448 0
Country [3] 449 0
Korea, Republic Of
State/province [3] 449 0
Country [4] 450 0
Viet Nam
State/province [4] 450 0
Country [5] 451 0
Philippines
State/province [5] 451 0
Country [6] 452 0
Taiwan, Province Of China
State/province [6] 452 0
Country [7] 453 0
Thailand
State/province [7] 453 0
Country [8] 454 0
Indonesia
State/province [8] 454 0
Country [9] 455 0
Singapore
State/province [9] 455 0
Country [10] 456 0
Malaysia
State/province [10] 456 0

Funding & Sponsors
Funding source category [1] 2084 0
Commercial sector/Industry
Name [1] 2084 0
GlaxoSmithKline International Medical, Asia Pacific
Address [1] 2084 0
150 Beach Road #22-00 Gateway, post code 189720
Country [1] 2084 0
Singapore
Primary sponsor type
Other Collaborative groups
Name
Baker IDI Heart and Diabetes Institute
Address
250 Kooyong Road
Caulfield VIC 3162
Country
Australia
Secondary sponsor category [1] 1890 0
None
Name [1] 1890 0
N/A
Address [1] 1890 0
Country [1] 1890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3875 0
International Diabetes Institute
Ethics committee address [1] 3875 0
Ethics committee country [1] 3875 0
Australia
Date submitted for ethics approval [1] 3875 0
Approval date [1] 3875 0
29/09/2006
Ethics approval number [1] 3875 0
Project 4/2006

Summary
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 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. The data collection will be over 12 months and 376 subjects will be recruited from 94 sites (4 subjects per site) in ten Asian countries (China, Hong Kong, Indonesia, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand and Vietnam).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27446 0
Prof Paul Zimmet
Address 27446 0
Prof Paul Zimmet: Department of Diabetes, Monash University, Level 6, Alfred Centre, 99 Commercial Road, Melbourne VIC 3004
Country 27446 0
Australia
Phone 27446 0
+61 3 9903 0254
Fax 27446 0
Email 27446 0
paul.zimmet@monash.edu
Contact person for public queries
Name 10701 0
Prof Jonathan Shaw
Address 10701 0
Baker Heart and Diabetes Institute, Level; 4, 99 Commercial Road, Melbourne VIC 3004
Country 10701 0
Australia
Phone 10701 0
+61 3 8532 1821
Fax 10701 0
61 3 8532 1100
Email 10701 0
jonathan.shaw@baker.edu.au
Contact person for scientific queries
Name 1629 0
Prof Jonathan Shaw
Address 1629 0
Baker Heart and Diabetes Institute, Level; 4, 99 Commercial Road, Melbourne VIC 3004
Country 1629 0
Australia
Phone 1629 0
+61 3 8532 1821
Fax 1629 0
61 3 8532 1100
Email 1629 0
jonathan.shaw@baker.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The trial concluded and was published before mandatory data sharing was required.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 815 0
Diabetes Res Clin Pract. 2012 Oct;98(1):38-45. doi:
10.1016/j.diabres.2012.06.002. Epub 2012 Jul 10.

The GIANT study, a cluster-randomised controlled trial of efficacy of education
of doctors about type 2 diabetes mellitus management guidelines in primary care
practice.

Reutens AT(1), Hutchinson R, Van Binh T, Cockram C, Deerochanawong C, Ho LT, Ji
L, Khalid BA, Kong AP, Lim-Abrahan MA, Tan CE, Tjokroprawiro A, Yoon KH, Zimmet
PZ, Shaw JE.
Attachments [1] 815 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary