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Lasting Benefit Seen for Lifestyle Changes, Metformin in Diabetes

Posted: Sunday, February 28, 2010

For people at risk for Type 2 diabetes, a combination of diet, exercise and, to a lesser extent, treatment with metformin can help keep the disease at bay for 10 years, researchers said.

Individuals who participated in a randomized, placebo-controlled trial of metformin and diet-and-exercise programs showed significantly reduced incidence of overt Type 2 diabetes over a 10-year follow-up, according to William C. Knowler, MD, PhD, MPH, of the National Institute of Diabetes and Digestive and Kidney Diseases in Bethesda, Md., and colleagues on the Diabetes Prevention Program Research Group.

The study examined long-term outcomes following the initial randomized trial, which lasted about three years.

In The Lancet, the researchers said people initially assigned to diet and physical activity modifications showed a 34% reduction in later diagnosis of Type 2 diabetes during follow-up, relative to the original placebo group.

Another group assigned to metformin treatment were at 18% less risk for Type 2 diabetes compared with the placebo group.

"Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years," Knowler and colleagues wrote. Follow-up of study participants is continuing, they added, with future reports to focus on both microvascular and cardiovascular outcomes.

Beginning in 1996, the original study assigned more than 3,800 people showing impaired glucose tolerance, but not full-blown diabetes, to participate in an intensive diet-and-exercise program, to receive metformin, or to receive placebo.

The randomized phase ended in 2001, when results showed a 58% reduction in diabetes diagnoses in the lifestyle intervention group and a 31% reduction in the metformin group, both relative to placebo.

About 2,750 of the participants, distributed nearly equally among the original assignment groups, were then followed for approximately seven years -- that is, 10 years from initial randomization.

Participants did not necessarily stay on their originally assigned interventions during the follow-up period. In fact, there was a drug washout period at the end of the randomized portion, such that all participants in the metformin group were off the drug for at least one to two weeks.

The core elements of the lifestyle modification program were offered to all participants when the randomized phase ended, out of ethical considerations.

By year 10, losses to follow-up left the researchers with full data on 2,240 people.

Knowler and colleagues found that, after the randomized phase ended, diabetes incidence rates were similar in all three groups: 5.9 per 100 person-years for the diet-and-exercise group (95% CI 5.1 to 6.8), 4.9 in the metformin group (95% CI 4.2 to 5.7), and 5.6 in the placebo group (95% CI 4.8 to 6.5).

The difference in 10-year outcomes, therefore, reflected persistence of the effects seen during the initial randomized portion of the trial, the researchers said.

In addition to diabetes incidence, the researchers also tracked body weight as a secondary endpoint.

Participants in the metformin group lost about 2 kg in the first year of the trial, which was maintained during the rest of the randomized phase and throughout the follow-up.

During the randomized phase, participants in the diet-and-exercise arm lost a mean of almost 7 kg in the first year, but regained weight in the next two years, for a net loss at year three of about 4 kg. By year five, the net loss had shrunk to 2 kg, which continued to the end of follow-up. Little change was seen in placebo patients' weight throughout the 10-year study.

However, when looking only at participants 60 and older at randomization, those assigned to the diet-and-exercise program steadily regained weight throughout the study after an initial 7-kg loss, whereas those in the metformin and placebo groups both lost weight after the randomized trial ended.

By year 10, weight loss in this older population relative to baseline was nearly identical for all three treatment groups, at about 4 kg.
Practice Pearls:

Explain that people at risk for Type 2 diabetes who lose weight and increase their physical activity are substantially less likely to develop the disease.

Explain that poor diet, excessive body weight, and sedentary lifestyles are strong risk factors for Type 2 diabetes.

Source: Diabetes In Control: Diabetes Prevention Program Research Group "10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study" Lancet 2009; DOI: 10.1016/S0140-6736(09)61457-4. Misra A "Prevention of Type 2 diabetes: The long and winding road" Lancet 2009; DOI: 10.1016/S0140-6736(09)61631-7.

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