What is all the fuss about the ACCORD study and the ADVANCE study? Both studies are trying to determine if reducing A1C to less than 6.5 is safe and effective in controlling type 2 diabetes and in lowering the risks for complications.  There is a fundamental flaw in both studies.

The flaw is the assumption by the researchers that medicating type 2 diabetes is the best strategy. In this type 2 diabetic's opinion there is fairly clear evidence that diet and exercise is the best and safest strategy.I have included exerts from all three studies and ask you to carefully consider each in determining your control options.

It should be noted that all three studies indicate good blood glucose control is desirable in combating the risks of diabetic complications from poorly controlled blood glucose resulting in elevated glycated hemoglobin (A1C above 7%) The ACCORD study was halted when one of the drugs in question was linked to higher risk of death. The ADVANCE study was using a sulfonylurea drug, gliclazide modified release, for all patients and a range of other drugs for those not reaching target blood glucose levels.

One additional study should be included with this article and I will include it by reference and ask you to review it at http://www.diabetes.ca/files/study-fact-sheet-final.doc This is the Diabetes In Canada Evaluation (DICE) The DICE study stated: Type 2 diabetes is a complex disease with a high burden of complications, all of which family physicians are having to manage in their daily practice. Current practices are not aggressive enough to manage a substantial proportion of type 2 diabetes patients.

Nearly half (49 per cent) of patients were not at target blood sugar levels (A1C ≤ 7 per cent). Almost one-third (32 per cent) of patients achieved sub-optimal levels (A1C ≤ 7 per cent to 8.4 per cent). Seventeen per cent of patients had inadequate blood sugar levels (A1C above 8.4 per cent).

As type 2 diabetics, it is our responsibility to stay abreast of current research. It is the responsibility of this site to bring you all recent and relevant information to help you make informed choices.

This is the abstract of a study comparing "lifestyle intervention" to drug therapy.

Diabetes Prevention Program Coordinating Center, Biostatistics Center, George Washington University, 6110 Executive Blvd., Suite 750, Rockville, MD 20852, USA.

BACKGROUND: Type 2 diabetes affects approximately 8 percent of adults in the United States. Some risk factors--elevated plasma glucose concentrations in the fasting state and after an oral glucose load, overweight, and a sedentary lifestyle--are potentially reversible. We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes. METHODS: We randomly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo, metformin (850 mg twice daily), or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week. The mean age of the participants was 51 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 34.0; 68 percent were women, and 45 percent were members of minority groups. RESULTS: The average follow-up was 2.8 years. The incidence of diabetes was 11.0, 7.8, and 4.8 cases per 100 person-years in the placebo, metformin, and lifestyle groups, respectively. The lifestyle intervention reduced the incidence by 58 percent (95 percent confidence interval, 48 to 66 percent) and metformin by 31 percent (95 percent confidence interval, 17 to 43 percent), as compared with placebo; the lifestyle intervention was significantly more effective than metformin. To prevent one case of diabetes during a period of three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin. CONCLUSIONS: Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk. The lifestyle intervention was more effective than metformin.

PMID: 11832527 [PubMed - indexed for MEDLINE]

The importance of managing type 2 diabetes by diet and lifestyle adjustments (call commonly 'lifestyle intervention' in the medical jargon).

In this study, the diabetes medication 'Metformin' was compared to a placebo, and to a 'lifestyle intervention' (weight loss and exercise through better diet and a very modest exercise program). The original article as in 'The New England Journal of Medicine', Feb 7, 2002 titled "Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin" and performed by the Diabetes Prevention Program Research Group".

In the study of over 3000 adult non-diabetics at high risk for developing type 2 diabetes, after just under 3 years in the study, the metformin only reduced the incidence of type 2 diabetes by 31% while the lifestyle intervention program reduced the incidence of type 2 diabetes by 58% (both relative to the placebo). That is a huge difference.

Not only did the lifestyle change dramatically reduce the chance that the people in the study developed type 2 diabetes, but the lifestyle intervention far exceeded the medication in its protective health benefits against developing type 2 diabetes.

The message here is that the most important thing you can do to fight type 2 diabetes is to modify your diet and lifestyle. You may require medications eventually as well, but your most important weapon against type 2 diabetes is your choosing to live a healthy lifestyle (exercise and diet)

On this site we strive to bring you the best methods of controlling type 2 diabetes with diet.

There are two additional studies that should be considered in this equation. They are the ACCORD study and the ADVANCE study.

ACCORD Study

Position Statement:  The National Heart, Lung, and Blood Institute

Issue: Part of ACCORD study halted due to safety concerns

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has halted the intensive blood-glucose lowering arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study 18 months early due to safety concerns.

This trial, carried out in 10,251 adults with type 2 diabetes at especially high risk for heart attack and stroke, was designed to compare the effect of two treatment strategies on the risk of cardiovascular events such as heart attack, stroke, or death from cardiovascular disease.

Participants were assigned to receive one of two strategies: treatment to intensively lower blood glucose below current recommendations or treatment with a less-intensive standard strategy. Over an average of almost four years, 257 people in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year (although the death rates in both treatment groups are lower than rates seen in similar populations in other studies). Based on available analyses there is no evidence that any one medication or any particular combination of medications is responsible for these deaths.

While the exact reasons for these findings are unclear, they do suggest that intensive treatment to target blood glucose levels below an A1C of 6.0% may not be appropriate for some patients, especially those at high risk of heart attack or stroke and with poor initial glycemic control. A target A1C =7.0% (as recommended for most patients with diabetes in the 2003 Canadian Diabetes Association's Clinical Practice Guidelines) offers physicians the option of aiming lower if they feel it is safe in an individual patient.

The ACCORD findings do not apply to people with type 1 diabetes, and it is unclear whether they apply to patients recently diagnosed with type 2 diabetes or those who have a lower cardiovascular risk than the participants in ACCORD.

It is important that people with diabetes not make any changes to their treatments or adjust their blood glucose targets without speaking to their healthcare team. In addition to blood glucose control, people with diabetes can reduce their overall cardiovascular risk by controlling their blood pressure and cholesterol levels and by adopting a healthy lifestyle that includes quitting smoking.

The ACCORD trial will continue, with participants in the intensive treatment arm now receiving standard treatment instead.

ADVANCE Study

Major international diabetes study (ADVANCE) does not confirm increased risk of death reported by US trial. (ACCORD)

http://www.advance-trial.com/static/upload/PDF/Media_release_Feb08.pdf

Download the Media release

Preliminary findings from the largest-ever study of treatments for diabetes provide no evidence that intensive treatment to lower blood glucose (sugar) increases risk of death

Interim results from the ADVANCE Study, involving 11,140 high-risk patients with type 2 diabetes, provide no evidence of an increased risk of death among those patients receiving intensive treatment to lower blood glucose (sugar).

These findings contrast with those reported last week by the US National Heart Lung and Blood Institute suggesting that intensive glucose lowering treatment levels had increased the death rate among patients with diabetes recruited to the ACCORD trial.

ADVANCE was designed to answer two questions in patients with type 2 diabetes: first, does intensive treatment to lower blood pressure improve outcome; and second, does intensive treatment to reduce blood glucose improve outcome.

In September 2007, the ADVANCE Collaborative Group published evidence in The Lancet showing that the blood pressure lowering treatment had reduced the death rate among participants. In January 2008, the part of the study designed to assess the effects of the intensive treatment to reduce blood glucose was completed. As in ACCORD, this intensive treatment program was designed to lower blood glucose to levels below those usually recommended by clinical guidelines.

Chairman of the ADVANCE Data Monitoring and Safety Committee, Professor Rory Collins from the University of Oxford, said "The interim results from ADVANCE provide no confirmation of the adverse mortality trend reported from the ACCORD study." He also noted that the ADVANCE interim results were based on more than twice as much data and similar levels of glucose control as in ACCORD. The members of the Data Monitoring and Safety Committee are the only members of ADVANCE study team with access to the study results.

ADVANCE principal investigator, Professor Stephen MacMahon from The George Institute for International Health in Sydney, stated that "Due to the unexpected report from the ACCORD trial, we felt it was in the public interest for us to ask our Data Monitoring and Safety Committee to make a statement as to whether the available data from ADVANCE provide any support for the suggestion that intensive blood glucose lowering may increase mortality."

In ADVANCE, the intensive blood glucose lowering program aimed to reduce levels of haemoglobin A1c (a marker of long term blood glucose control) to below 6.5%. This treatment regimen included a sulfonylurea drug, gliclazide modified release, for all patients and a range of other drugs for those not reaching target blood glucose levels.

ADVANCE commenced in July 2001 and patients were treated and followed-up for an average of five years. The Data Monitoring and Safety Committee, comprising a panel of independent experts in the field, met every six months to review the study data for any safety issues or other concerns.

ADVANCE Management Committee Chairman, Professor John Chalmers, commented "Doctors and patients should feel reassured that the mortality trend reported by the ACCORD study has not been found in the interim results from ADVANCE. However, we need to await more definitive analyses and reports from both studies before drawing final conclusions".

"Final patient visits have been completed, and the ADVANCE study data base is close to finalisation. We expect to have definitive results soon," said Study Director, Dr Anushka Patel, from The George Institute. "At this stage, the Data Monitoring and Safety Committee have reviewed results that are more than 99% complete, so we are confident that the interim findings communicated here are a reliable guide to the final results".

ADVANCE was conducted by an independent collaborative group of medical researchers, with support from the National Health & Medical Research Council of Australia and the Paris-based, Institute de Recherche Internationales Servier.

Bottom line: While the medical establishment under the influence of the pharmaceutical companies is still stuck in the "drug therapy" mode, there are ever increasing numbers of type 2 diabetics discovering they can get A1C as good, or better than the results obtained with medication through nutrition and lifestyle changes.  You and your medical practitioner need to decide what is best for you. One thing we can all agree on is the desirability of keeping your A1C under 7%. Many experts are recommending under 6.5 % and some are saying keep A1C under 6% if you can do so safely. My A1c has been between 5.0 and 5.6 for the past 3 years without medications and many if not all of my diabetic symptoms have reversed. I am other type 2 diabetics are maintaining non-diabetic A1C levels through proper diet.