In a controlled trial, 600 overweight
and obese people with prediabetes were given metformin in Chennai,India.
Metformin is in the biguanide class.
It works by decreasing glucose production by the liver and increasing
the insulin sensitivity of body tissues. It also can possibly help
patients to lose weight, and possibly prevent some forms of cancer.
Metformin was discovered in 1922. It is on the World Health
Organization’s List of Essential Medicines, the most important
medications needed in a basic healthcare system. Metformin is
believed to be the most widely used medication for diabetes, which is
taken by mouth. It is available as a generic medication.
For those patients who are under age 60
with prediabetes, the ADA has recommended metformin for those with a
BMI over 34 and for women with gestational diabetes in the past.
But, for others, especially for those over the age of 60, and even
teenagers who rarely are treated with metformin, the study found that
just 3.7% of those with prediabetes were actually prescribed
metformin, over a 3-year period. Since metformin has been around
since 1950 and even longer overseas and has even been shown to
possibly prevent certain kinds of cancer, why should it not be
standard procedure to provide all those with prediabetes the option
to be treated with metformin?
With the cost for the 29 million
patients with diabetes at over 300 billion dollars, should we be
asking the question: with more than 90 million people in the U.S.
with prediabetes — a number that’s still growing — why doesn’t
the FDA or the ADA recommend starting patients on metformin
immediately after diagnosis?
In a randomized controlled trial of
almost 600 overweight or obese people with prediabetes in Chennai,
India, significantly fewer of those who followed an intensive
lifestyle-intervention program, with metformin if needed, went on to
develop diabetes compared with persons managed with standard care.
But, the intervention’s effectiveness varied according to
differences in the metabolic nature of their prediabetes.
The intervention in the trial, called
the Diabetes Community Lifestyle Improvement Program (D-CLIP), was
modeled after the U.S. Diabetes Prevention Program (DPP), but adapted
for India. It consisted of 4 months of weekly educational sessions
on diet and exercise, followed by a 2-month maintenance program of
weekly educational meetings, plus metformin as needed.
Patients in the intervention arm who
had both impaired fasting glucose (IFG) and impaired glucose
tolerance (IGT) showed a 36% lower risk of developing diabetes
compared with those in the control arm. And those with only isolated
IGT had a 31% lower risk. But the benefit was smaller in patients
with only isolated IFG at baseline; they showed a 12% lower risk of
developing diabetes.
Participants in the control arm
received standard care, which consisted of a one-time visit with a
physician, a dietitian, and a fitness trainer, and a group class on
diabetes prevention (with instruction on, for example, how to follow
a low-fat diet rich in complex carbohydrates and fresh fruits and
vegetables, and how to increase physical activity), but none received
metformin. Low-fat diet has to have been a factor in the study and
caused some data irregularities.
Participants in the intervention group
received 16 weekly core classes for 4 months followed by eight weekly
maintenance classes for 2 months. The classes were 1.5 hours long,
for groups of eight to 24 participants, and included an exercise
class following the educational talk.
The intervention’s goals were the
same as those in the DPP: greater than 7% weight loss and greater
than 150 minutes/week of moderate-intensity exercise. At 4 months,
participants who still had IFG and either IGT or HbA1c greater than
5.7% received 500 mg twice-daily metformin. During the 3-year
follow-up, a per-year mean of 11.1% of participants in the control
group vs 7.8% of participants in the intervention group developed
diabetes (P = .014). The number needed to treat to prevent
one case of diabetes with the intervention was 9.8.
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