Diabetes Mellitus, Type 2Phase 3NCT00145925
Blood Pressure and Glucose Lowering for the Prevention of Vascular Disease in High Risk Patients With Type 2 Diabetes
A Phase 3 study testing Perindopril-indapamide and Gliclazide MR-based glucose lowering in people with Diabetes Mellitus, Type 2, run by The George Institute at 5 sites in 5 countries.
Trial summary
The purpose of this study is to provide information on the risks and benefits of routine blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. Read more about this study
- Who is it for?
- Ages 55 to 110 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Perindopril-indapamide and Gliclazide MR-based glucose lowering
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,140 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Jun 2001to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of type 2 diabetes mellitus first made at age 30 years or older
- Age 55 years or older at entry
- Ability to provide informed consent
- A substantially elevated risk of cardiovascular disease, indicated by:
- A history of major macrovascular disease defined as any one of: stroke, myocardial infarction, hospital admission for transient ischaemic attack, hospital admission for unstable angina, coronary artery bypass graft, percutaneous transluminal coronary angioplasty (with or without stenting), peripheral revascularisation (angioplasty or surgery) or amputation secondary to vascular disease or
- A history of major microvascular disease defined as any one of nephropathy (albumin:creatinine ratio >300ug/mg), retinal photocoagulation therapy, proliferative retinopathy (new blood vessels on the disc or elsewhere, vitreous haemorrhage, pre-retinal haemorrhage, or fibrous proliferations on the disc or elsewhere), macular oedema (retinal thickening within one disc diameter of the macular centre) or blindness in either eye (corrected visual acuity 6/60 or worse, persisting for three months or more) not known to be due to non-diabetic causes or
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- A first diagnosis of type 2 diabetes made 10 or more years prior to entry or
- Another major risk factor for vascular disease defined as any one of: current daily cigarette smoking, total cholesterol greater than 6.0 mmol/l (with or without cholesterol lowering treatment), HDL cholesterol <1.0 mmol/l, microalbuminuria (albumin:creatinine ratio 30-300ug/mg) or
- Age 65 years or over
Who cannot join
- A definite contraindication to treatment with an ACE inhibitor or a thiazide-like diuretic
- A specific indication for treatment with an ACE inhibitor other than perindopril 2-4 mg daily (see also section 5.2.3) or a thiazide-like diuretic
- A definite and specific indication for treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
- A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
- A definite indication for long-term full-dose or bed-time insulin therapy
- Participation in a trial within the month prior to the Registration Visit or current participation in another trial
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- Other potential reasons for ineligibility include:
- High probability of non-adherence to study treatment or follow-up
- Current clinical instability (e.g. a major cerebral or coronary event or sight-threatening retinopathy or macular oedema within the previous few weeks)
- Life threatening non-vascular disease other than diabetes and its complications
- Moderate or severe dementia
- Major disability that is likely to prevent regular attendance at study clinics
- Final decisions about eligibility were made at the discretion of the study investigator and the potential study participant, in the light of any requirements or guidance from local ethics committees and other regulatory bodies.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
China1 site
Cardiovascular Institute & Fu Wai Hospital
Beijing, Beijing Municipality, 100037
Netherlands1 site
The Julius Center for Health Sciences and Primary Care
Utrecht, Utrecht, 3508 BA
United Kingdom1 site
Imperial College School of Medicine
London, W2 1PG
About this study
Official title: ADVANCE - Action in Diabetes and Vascular Disease: Preterax and Diamicron - MR Controlled Evaluation
The purpose of this study is to provide information on the risks and benefits of routine blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. The major outcomes of the study will be cardiovascular events (heart attack, stroke or dying as a result of cardiovascular disease), as well as new or worsening diabetic eye and kidney disease.
Read the detailed description
Patients with type 2 diabetes are at increased risks of macrovascular and microvascular disease, both of which are reduced by control of raised blood pressure in hypertensive individuals. Intensive glycaemic control has also been shown to reduce microvascular disease, but the effects on macrovascular disease remain uncertain. This study will examine the hypotheses that blood pressure lowering (with an ACE inhibitor-diuretic combination) and intensive glycaemic control (with a sulphonylurea-based regimen) in high-risk individuals with type 2 diabetes (including hypertensive and non-hypertensive subjects) reduces the incidence of both macrovascular and microvascular disease.
The study is a 2 x 2 factorial randomised controlled trial that includes 11,140 adults with type 2 diabetes at elevated risk of vascular disease. Following 6 weeks on open label perindopril-indapamide combination, eligible individuals were randomised to continued perindopril-indapamide or matching placebo, and to an intensive gliclazide MR-based glucose control regimen (aiming for HbA1c of 6.5% or lower) or usual guidelines-based therapy. Primary outcomes are, first, the composite of non-fatal stroke, non-fatal myocardial infarction or cardiovascular death and, second, the composite of new or worsening nephropathy or diabetic eye disease. These primary outcomes will be analysed jointly and separately. The average duration of treatment and follow-up is 5.5 to 6 years. The study is being conducted in 214 centres in Australasia, Asia, Europe and North America.
ADVANCE is designed to provide reliable evidence about the balance of benefits and risks conferred by blood pressure lowering therapy and intensive glucose control therapy in high-risk diabetic patients, irrespective of initial blood pressure or glucose levels.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Perindopril-indapamide, Gliclazide MR-based glucose lowering
- Keywords
- Diabetes Mellitus, Type 2, Blood Pressure, Stroke, MI
- Medical subject headings
- Diabetes Mellitus, Type 2, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perindopril-indapamideDrug
Gliclazide MR-based glucose loweringDrug
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure | Placebo comparator | Perindopril indapamide vs placebo Receives: Drug: Perindopril-indapamide |
| Glucose control | Other | Standard versus intensive glucose control Receives: Drug: Gliclazide MR-based glucose lowering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause
Measured: July 2001 - December 2007
Composite of new or substantially worsening nephropathy or microvascular eye disease.
Measured: July 2001 - December 2007
Secondary outcomes (1)
Includes cerebrovascular disease, coronary heart disease, heart failure, peripheral vascular disease, cardiovascular and all-cause mortality, microalbuminuria, visual deterioration, new or worsening nephropathy, cognitive function, and dementia.
Measured: July 2001 - December 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJun 2001
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 11,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherches Internationales Servier, University of Sydney, National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- John Chalmers, MB BS PhD, Principal investigator, The George InstituteStephen W MacMahon, BSc PhD MPH, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145925
- Sponsor's protocol ID
- ADVANCE
- Status last verified
- Sep 2008
- First submitted
- 2 Sep 2005
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rationale and design of the ADVANCE study: a randomised trial of blood pressure lowering and intensive glucose control in high-risk individuals with type 2 diabetes mellitus. Action in Diabetes and Vascular Disease: PreterAx and DiamicroN Modified-Release Controlled Evaluation. J Hypertens Suppl. 2001 Nov;19(4):S21-8.
PubMed 11848259ADVANCE Collaborative Group. ADVANCE--Action in Diabetes and Vascular Disease: patient recruitment and characteristics of the study population at baseline. Diabet Med. 2005 Jul;22(7):882-8. doi: 10.1111/j.1464-5491.2005.01596.x.
PubMed 15975103ADVANCE Management Committee. Study rationale and design of ADVANCE: action in diabetes and vascular disease--preterax and diamicron MR controlled evaluation. Diabetologia. 2001 Sep;44(9):1118-20. doi: 10.1007/s001250100612.
PubMed 11596665Bompoint S, Billot L, Patel A, Woodward M, Harris K, Harrap S, Mancia G, Poulter N, Chalmers J. Effect of intensive blood pressure and blood glucose control on cardiovascular outcomes driven by reductions in cardiovascular death and nephropathy: win ratio analysis of ADVANCE trial. Eur Heart J Cardiovasc Pharmacother. 2026 Jul 14;12(4):258-268. doi: 10.1093/ehjcvp/pvag026.
PubMed 42056835Shajahan S, Woodward M, Anderson CS, Carcel C, Wang N, Tully PJ, Peters R, Harrap S, Poulter N, Mancia G, MacMahon S, Chalmers J, Harris K. Blood Pressure Parameters and Risk of Cognitive Decline and Dementia in Type 2 Diabetes: Results From the ADVANCE Trial. J Am Heart Assoc. 2026 Apr 7;15(7):e044061. doi: 10.1161/JAHA.125.044061. Epub 2026 Mar 31.
PubMed 41914351Wang R, Zhang Y, Gao Y, Chen L, Chen X, Peters R, Anderson CS, Marre M, Harrap S, Hamet P, Mancia G, Woodward M, Chalmers J, Harris K. Estimated Glucose Disposal Rate and Risk of Vascular Events and Death in Type 2 Diabetes in the ADVANCE Study. Diabetes Obes Metab. 2026 May;28(5):4176-4184. doi: 10.1111/dom.70608. Epub 2026 Mar 9.
PubMed 41804187You S, Zheng D, Wang Y, Li Q, Nguyen TN, Peters R, Chen X, Wang X, Cao Y, Grobbee DE, Harrap S, Mancia G, Williams B, Poulter NR, Lisheng L, Marre M, Hamet P, Anderson CS, Woodward M, Chalmers J, Harris K. Healthy lifestyle factors and combined macrovascular and microvascular events in diabetes patients with high cardiovascular risk: results from ADVANCE. BMC Med. 2025 Feb 12;23(1):87. doi: 10.1186/s12916-025-03932-3.
PubMed 39939937Harris K, Gong J, MacMahon S, Xu Y, Shajahan S, Harrap S, Poulter N, Marre M, Hamet P, Mancia G, Anderson C, Woodward M, Chalmers J. Effect of randomised blood pressure lowering treatment and intensive glucose control on dementia and cognitive decline according to baseline cognitive function and other subpopulations of individuals with type 2 diabetes: Results from the ADVANCE trial. Cereb Circ Cogn Behav. 2024 Dec 5;8:100372. doi: 10.1016/j.cccb.2024.100372. eCollection 2025.
PubMed 39758508Wang N, Harris K, Woodward M, Harrap S, Mancia G, Poulter N, Chalmers J, Rodgers A; PROGRESS and ADVANCE collaborators. Clinical Utility of Short-Term Blood Pressure Measures to Inform Long-Term Blood Pressure Management. Hypertension. 2023 Mar;80(3):608-617. doi: 10.1161/HYPERTENSIONAHA.122.20458. Epub 2022 Dec 5.
PubMed 36468403Ohkuma T, Harris K, Cooper M, Grobbee DE, Hamet P, Harrap S, Mancia G, Marre M, Patel A, Rodgers A, Williams B, Woodward M, Chalmers J; ADVANCE Collaborative Group. Short-Term Changes in Serum Potassium and the Risk of Subsequent Vascular Events and Mortality: Results from a Randomized Controlled Trial of ACE Inhibitors. Clin J Am Soc Nephrol. 2022 Aug;17(8):1139-1149. doi: 10.2215/CJN.00180122. Epub 2022 Jul 27.
PubMed 35896277Juraschek SP, Wang D, McEvoy JW, Harrap S, Harris K, Mancia G, Marre M, Neal B, Patel A, Poulter NR, Williams B, Chalmers J, Woodward M, Selvin E. Effects of glucose and blood pressure reduction on subclinical cardiac damage: Results from ADVANCE. Int J Cardiol. 2022 Jul 1;358:103-109. doi: 10.1016/j.ijcard.2022.04.044. Epub 2022 Apr 18.
PubMed 35439582Harris K, Muntner P, Woodward M, Jun M, Oshima M, Gong J, Harrap S, Menard J, Chalmers J. Clinical outcomes by atherosclerotic cardiovascular disease risk score and blood pressure level in high risk individuals with type 2 diabetes. J Hum Hypertens. 2023 Mar;37(3):181-188. doi: 10.1038/s41371-022-00661-5. Epub 2022 Feb 19.
PubMed 35184142Nguyen TN, Harris K, Woodward M, Chalmers J, Cooper M, Hamet P, Harrap S, Heller S, MacMahon S, Mancia G, Marre M, Poulter N, Rogers A, Williams B, Zoungas S, Chow CK, Lindley RI. The Impact of Frailty on the Effectiveness and Safety of Intensive Glucose Control and Blood Pressure-Lowering Therapy for People With Type 2 Diabetes: Results From the ADVANCE Trial. Diabetes Care. 2021 Jul;44(7):1622-1629. doi: 10.2337/dc20-2664. Epub 2021 May 25.
PubMed 34035077Wang N, Harris K, Chalmers J, Harrap S, Mancia G, Marre M, Poulter N, Tzourio C, Williams B, Zoungas S, Woodward M, Rodgers A. Combination blood pressure lowering in the presence or absence of background statin and aspirin therapy: a combined analysis of PROGRESS and ADVANCE Trials. J Hypertens. 2021 Aug 1;39(8):1689-1696. doi: 10.1097/HJH.0000000000002862.
PubMed 33883461Gong J, Harris K, Hackett M, Peters SAE, Brodaty H, Cooper M, Hamet P, Harrap S, Mancia G, MacMahon S, Chalmers J, Woodward M. Sex differences in risk factors for cognitive decline and dementia, including death as a competing risk, in individuals with diabetes: Results from the ADVANCE trial. Diabetes Obes Metab. 2021 Aug;23(8):1775-1785. doi: 10.1111/dom.14391. Epub 2021 May 4.
PubMed 33783955
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANCE - Action in Diabetes and Vascular Disease: Preterax and Diamicron - MR Controlled Evaluation
- ClinicalTrials.gov ID
- NCT00145925
- Acronym / sponsor ID
- ADVANCE
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Blood Pressure, Stroke, MI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,140 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- Institut de Recherches Internationales Servier, University of Sydney, National Health and Medical Research Council, Australia
- Study start
- Jun 2001
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide information on the risks and benefits of routine blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. The major outcomes of the study will be cardiovascular events (heart attack, stroke or dying as a result of cardiovascular disease), as well as new or worsening diabetic eye and kidney disease.
Detailed description
Patients with type 2 diabetes are at increased risks of macrovascular and microvascular disease, both of which are reduced by control of raised blood pressure in hypertensive individuals. Intensive glycaemic control has also been shown to reduce microvascular disease, but the effects on macrovascular disease remain uncertain. This study will examine the hypotheses that blood pressure lowering (with an ACE inhibitor-diuretic combination) and intensive glycaemic control (with a sulphonylurea-based regimen) in high-risk individuals with type 2 diabetes (including hypertensive and non-hypertensive subjects) reduces the incidence of both macrovascular and microvascular disease.
The study is a 2 x 2 factorial randomised controlled trial that includes 11,140 adults with type 2 diabetes at elevated risk of vascular disease. Following 6 weeks on open label perindopril-indapamide combination, eligible individuals were randomised to continued perindopril-indapamide or matching placebo, and to an intensive gliclazide MR-based glucose control regimen (aiming for HbA1c of 6.5% or lower) or usual guidelines-based therapy. Primary outcomes are, first, the composite of non-fatal stroke, non-fatal myocardial infarction or cardiovascular death and, second, the composite of new or worsening nephropathy or diabetic eye disease. These primary outcomes will be analysed jointly and separately. The average duration of treatment and follow-up is 5.5 to 6 years. The study is being conducted in 214 centres in Australasia, Asia, Europe and North America.
ADVANCE is designed to provide reliable evidence about the balance of benefits and risks conferred by blood pressure lowering therapy and intensive glucose control therapy in high-risk diabetic patients, irrespective of initial blood pressure or glucose levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood pressure | Placebo comparator | Drug: Perindopril-indapamidePerindopril indapamide vs placebo |
| Glucose control | Other | Drug: Gliclazide MR-based glucose loweringStandard versus intensive glucose control |
Who may qualify
- Ages
- 55 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A diagnosis of type 2 diabetes mellitus first made at age 30 years or older
- Age 55 years or older at entry
- Ability to provide informed consent
- A substantially elevated risk of cardiovascular disease, indicated by:
Key exclusion criteria (13 listed)
- A definite contraindication to treatment with an ACE inhibitor or a thiazide-like diuretic
- A specific indication for treatment with an ACE inhibitor other than perindopril 2-4 mg daily (see also section 5.2.3) or a thiazide-like diuretic
- A definite and specific indication for treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
- A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
- A definite indication for long-term full-dose or bed-time insulin therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perindopril-indapamide | Drug | Blood pressure |
| Gliclazide MR-based glucose lowering | Drug | Glucose control |
Primary outcome
Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause
Time frame: July 2001 - December 2007
Composite of new or substantially worsening nephropathy or microvascular eye disease.
Time frame: July 2001 - December 2007
1 secondary outcome
Includes cerebrovascular disease, coronary heart disease, heart failure, peripheral vascular disease, cardiovascular and all-cause mortality, microalbuminuria, visual deterioration, new or worsening nephropathy, cognitive function, and dementia.
Time frame: July 2001 - December 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 11848259Rationale and design of the ADVANCE study: a randomised trial of blood pressure lowering and intensive glucose control in high-risk individuals with type 2 diabetes mellitus. Action in Diabetes and Vascular Disease: PreterAx and DiamicroN Modified-Release Controlled Evaluation. J Hypertens Suppl. 2001 Nov;19(4):S21-8.
- Background: PubMed 15975103ADVANCE Collaborative Group. ADVANCE--Action in Diabetes and Vascular Disease: patient recruitment and characteristics of the study population at baseline. Diabet Med. 2005 Jul;22(7):882-8. doi: 10.1111/j.1464-5491.2005.01596.x.
- Background: PubMed 11596665ADVANCE Management Committee. Study rationale and design of ADVANCE: action in diabetes and vascular disease--preterax and diamicron MR controlled evaluation. Diabetologia. 2001 Sep;44(9):1118-20. doi: 10.1007/s001250100612.
- Derived from this study: PubMed 42056835Bompoint S, Billot L, Patel A, Woodward M, Harris K, Harrap S, Mancia G, Poulter N, Chalmers J. Effect of intensive blood pressure and blood glucose control on cardiovascular outcomes driven by reductions in cardiovascular death and nephropathy: win ratio analysis of ADVANCE trial. Eur Heart J Cardiovasc Pharmacother. 2026 Jul 14;12(4):258-268. doi: 10.1093/ehjcvp/pvag026.
- Derived from this study: PubMed 41914351Shajahan S, Woodward M, Anderson CS, Carcel C, Wang N, Tully PJ, Peters R, Harrap S, Poulter N, Mancia G, MacMahon S, Chalmers J, Harris K. Blood Pressure Parameters and Risk of Cognitive Decline and Dementia in Type 2 Diabetes: Results From the ADVANCE Trial. J Am Heart Assoc. 2026 Apr 7;15(7):e044061. doi: 10.1161/JAHA.125.044061. Epub 2026 Mar 31.
- Derived from this study: PubMed 41804187Wang R, Zhang Y, Gao Y, Chen L, Chen X, Peters R, Anderson CS, Marre M, Harrap S, Hamet P, Mancia G, Woodward M, Chalmers J, Harris K. Estimated Glucose Disposal Rate and Risk of Vascular Events and Death in Type 2 Diabetes in the ADVANCE Study. Diabetes Obes Metab. 2026 May;28(5):4176-4184. doi: 10.1111/dom.70608. Epub 2026 Mar 9.
- Derived from this study: PubMed 39939937You S, Zheng D, Wang Y, Li Q, Nguyen TN, Peters R, Chen X, Wang X, Cao Y, Grobbee DE, Harrap S, Mancia G, Williams B, Poulter NR, Lisheng L, Marre M, Hamet P, Anderson CS, Woodward M, Chalmers J, Harris K. Healthy lifestyle factors and combined macrovascular and microvascular events in diabetes patients with high cardiovascular risk: results from ADVANCE. BMC Med. 2025 Feb 12;23(1):87. doi: 10.1186/s12916-025-03932-3.
- Derived from this study: PubMed 39758508Harris K, Gong J, MacMahon S, Xu Y, Shajahan S, Harrap S, Poulter N, Marre M, Hamet P, Mancia G, Anderson C, Woodward M, Chalmers J. Effect of randomised blood pressure lowering treatment and intensive glucose control on dementia and cognitive decline according to baseline cognitive function and other subpopulations of individuals with type 2 diabetes: Results from the ADVANCE trial. Cereb Circ Cogn Behav. 2024 Dec 5;8:100372. doi: 10.1016/j.cccb.2024.100372. eCollection 2025.
- Derived from this study: PubMed 36468403Wang N, Harris K, Woodward M, Harrap S, Mancia G, Poulter N, Chalmers J, Rodgers A; PROGRESS and ADVANCE collaborators. Clinical Utility of Short-Term Blood Pressure Measures to Inform Long-Term Blood Pressure Management. Hypertension. 2023 Mar;80(3):608-617. doi: 10.1161/HYPERTENSIONAHA.122.20458. Epub 2022 Dec 5.
- Derived from this study: PubMed 35896277Ohkuma T, Harris K, Cooper M, Grobbee DE, Hamet P, Harrap S, Mancia G, Marre M, Patel A, Rodgers A, Williams B, Woodward M, Chalmers J; ADVANCE Collaborative Group. Short-Term Changes in Serum Potassium and the Risk of Subsequent Vascular Events and Mortality: Results from a Randomized Controlled Trial of ACE Inhibitors. Clin J Am Soc Nephrol. 2022 Aug;17(8):1139-1149. doi: 10.2215/CJN.00180122. Epub 2022 Jul 27.
- Derived from this study: PubMed 35439582Juraschek SP, Wang D, McEvoy JW, Harrap S, Harris K, Mancia G, Marre M, Neal B, Patel A, Poulter NR, Williams B, Chalmers J, Woodward M, Selvin E. Effects of glucose and blood pressure reduction on subclinical cardiac damage: Results from ADVANCE. Int J Cardiol. 2022 Jul 1;358:103-109. doi: 10.1016/j.ijcard.2022.04.044. Epub 2022 Apr 18.
- Derived from this study: PubMed 35184142Harris K, Muntner P, Woodward M, Jun M, Oshima M, Gong J, Harrap S, Menard J, Chalmers J. Clinical outcomes by atherosclerotic cardiovascular disease risk score and blood pressure level in high risk individuals with type 2 diabetes. J Hum Hypertens. 2023 Mar;37(3):181-188. doi: 10.1038/s41371-022-00661-5. Epub 2022 Feb 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Chalmers, MB BS PhD principal investigator
The George Institute
Stephen W MacMahon, BSc PhD MPH principal investigator
The George Institute
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Perindopril-indapamide and Gliclazide MR-based glucose lowering in people with Diabetes Mellitus, Type 2, run by The George Institute at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Canada, China, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (time frame: July 2001 - December 2007). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00145925, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.